The U.S. Food and Drug Administration approved 481 drug products in May, according to an online list the agency updated this week.
The list includes original and supplemental approvals for new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs), the FDA said. Supplemental approvals might have been granted in the first week of April.
The FDA defines biologics as natural materials such as enzymes, antibodies or hormones in the human body.
---
FDA Drug Approvals in May
| Approval Date | Drug Name | Submission | Active Ingredients | Company | Submission Classification | Submission Status |
| May 1 | DIPROLENE NDA #018741 | SUPPL-40 | BETAMETHASONE DIPROPIONATE | MERCK SHARP DOHME | Labeling | Approval |
| May 1 | DIPROLENE AF NDA #019555 | SUPPL-35 | BETAMETHASONE DIPROPIONATE | MERCK SHARP DOHME | Labeling | Approval |
| May 1 | DIPROLENE NDA #019716 | SUPPL-33 | BETAMETHASONE DIPROPIONATE | MERCK SHARP DOHME | Labeling | Approval |
| May 1 | NORMOCARB HF 25 NDA #021910 | SUPPL-8 | MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | DIALYSIS SUPS | Labeling | Approval |
| May 1 | NORMOCARB HF 35 NDA #021910 | SUPPL-8 | MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | DIALYSIS SUPS | Labeling | Approval |
| May 1 | GEMCITABINE HYDROCHLORIDE ANDA #079160 | SUPPL-9 | GEMCITABINE HYDROCHLORIDE | ACTAVIS TOTOWA | Labeling | Approval |
| May 1 | GEMCITABINE HYDROCHLORIDE ANDA #079160 | SUPPL-10 | GEMCITABINE HYDROCHLORIDE | ACTAVIS TOTOWA | Labeling | Approval |
| May 1 | LAMIVUDINE ANDA #090198 | ORIG-1 | LAMIVUDINE | MACLEODS PHARMS LTD | Approval | |
| May 1 | GEMCITABINE HYDROCHLORIDE ANDA #091365 | SUPPL-7 | GEMCITABINE HYDROCHLORIDE | DR REDDYS LABS LTD | Labeling | Approval |
| May 1 | BLISOVI 24 FE ANDA #091398 | SUPPL-1 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | LUPIN LTD | Labeling | Approval |
| May 1 | BLISOVI 24 FE ANDA #091398 | SUPPL-5 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | LUPIN LTD | Labeling | Approval |
| May 1 | BLISOVI 24 FE ANDA #091398 | SUPPL-9 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | LUPIN LTD | Manufacturing (CMC) | Approval |
| May 1 | XOLAIR BLA #103976 | SUPPL-5234 | OMALIZUMAB | GENENTECH | Approval | |
| May 1 | NADOLOL ANDA #201893 | SUPPL-1 | NADOLOL | AUROBINDO PHARMA LTD | Manufacturing (CMC) | Approval |
| May 1 | DACTINOMYCIN ANDA #203385 | SUPPL-1 | DACTINOMYCIN | MYLAN LABS LTD | Labeling | Approval |
| May 1 | DAPTOMYCIN ANDA #208375 | ORIG-1 | DAPTOMYCIN | DR REDDYS | Approval | |
| May 1 | MEDROXYPROGESTERONE ACETATE ANDA #210760 | ORIG-1 | MEDROXYPROGESTERONE ACETATE | SUN PHARM | Approval | |
| May 1 | CALCIUM CHLORIDE 10% ANDA #211553 | ORIG-1 | CALCIUM CHLORIDE | MEDEFIL INC | Approval | |
| May 2 | ETOPOPHOS PRESERVATIVE FREE NDA #020457 | SUPPL-19 | ETOPOSIDE PHOSPHATE | BRISTOL MYERS SQUIBB | Labeling | Approval |
| May 2 | TOPAMAX NDA #020505 | SUPPL-60 | TOPIRAMATE | JANSSEN PHARMS | Labeling | Approval |
| May 2 | TOPAMAX NDA #020844 | SUPPL-51 | TOPIRAMATE | JANSSEN PHARMS | Labeling | Approval |
| May 2 | TOPAMAX SPRINKLE NDA #020844 | SUPPL-51 | TOPIRAMATE | JANSSEN PHARMS | Labeling | Approval |
| May 2 | REBETOL NDA #020903 | SUPPL-55 | RIBAVIRIN | MERCK SHARP DOHME | Labeling | Approval |
| May 2 | REBETOL NDA #021546 | SUPPL-11 | RIBAVIRIN | SCHERING | Labeling | Approval |
| May 2 | KUVAN NDA #022181 | SUPPL-19 | SAPROPTERIN DIHYDROCHLORIDE | BIOMARIN PHARM | Labeling | Approval |
| May 2 | PREDNISONE ANDA #088832 | SUPPL-35 | PREDNISONE | MYLAN | Manufacturing (CMC) | Approval |
| May 2 | OPDIVO BLA #125554 | SUPPL-73 | NIVOLUMAB | BRISTOL MYERS SQUIBB | Approval | |
| May 2 | BLISOVI FE 1.5/30 ANDA #201585 | SUPPL-5 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | LUPIN LTD | Labeling | Approval |
| May 2 | BLISOVI FE 1.5/30 ANDA #201585 | SUPPL-8 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | LUPIN LTD | Manufacturing (CMC) | Approval |
| May 2 | KUVAN NDA #205065 | SUPPL-5 | SAPROPTERIN DIHYDROCHLORIDE | BIOMARIN PHARM | Labeling | Approval |
| May 2 | TIMOLOL MALEATE ANDA #207556 | ORIG-1 | TIMOLOL MALEATE | INVATECH PHARMA | Approval | |
| May 2 | LEVONORGESTREL ANDA #207660 | ORIG-1 | LEVONORGESTREL | ACCORD HLTHCARE | Approval | |
| May 2 | QTERN NDA #209091 | SUPPL-2 | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE | ASTRAZENECA AB | Efficacy | Approval |
| May 2 | QTERNMET XR NDA #210874 | ORIG-1 | DAPAGLIFLOZIN;SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | ASTRAZENECA AB | Type 4 - New Combination | Approval |
| May 2 | TIBSOVO NDA #211192 | SUPPL-1 | IVOSIDENIB | AGIOS PHARMS INC | Efficacy | Approval |
| May 3 | FELDENE NDA #018147 | SUPPL-48 | PIROXICAM | PFIZER | Labeling | Approval |
| May 3 | DAYPRO NDA #018841 | SUPPL-30 | OXAPROZIN | GD SEARLE | Labeling | Approval |
| May 3 | CIPRO NDA #019537 | SUPPL-89 | CIPROFLOXACIN HYDROCHLORIDE | BAYER HLTHCARE | Labeling | Approval |
| May 3 | CIPRO NDA #019847 | SUPPL-60 | CIPROFLOXACIN | BAYER HLTHCARE | Labeling | Approval |
| May 3 | CIPRO IN DEXTROSE 5% IN
PLASTIC CONTAINER NDA #019857 | SUPPL-69 | CIPROFLOXACIN | BAYER HLTHCARE | Labeling | Approval |
| May 3 | LEVAQUIN NDA #020634 | SUPPL-72 | LEVOFLOXACIN | JANSSEN PHARMS | Labeling | Approval |
| May 3 | DAYPRO ALTA NDA #020776 | SUPPL-8 | OXAPROZIN POTASSIUM | GD SEARLE | Labeling | Approval |
| May 3 | CIPRO NDA #020780 | SUPPL-46 | CIPROFLOXACIN | BAYER HLTHCARE | Labeling | Approval |
| May 3 | CELEBREX NDA #020998 | SUPPL-54 | CELECOXIB | GD SEARLE | Labeling | Approval |
| May 3 | AVELOX NDA #021085 | SUPPL-65 | MOXIFLOXACIN HYDROCHLORIDE | BAYER HLTHCARE | Labeling | Approval |
| May 3 | FACTIVE NDA #021158 | SUPPL-26 | GEMIFLOXACIN MESYLATE | LG CHEM LTD | Labeling | Approval |
| May 3 | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER NDA #021277 | SUPPL-61 | MOXIFLOXACIN HYDROCHLORIDE | BAYER HLTHCARE | Labeling | Approval |
| May 3 | CIPRO XR NDA #021473 | SUPPL-40 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | BAYER HLTHCARE | Labeling | Approval |
| May 3 | VANCOMYCIN HYDROCHLORIDE ANDA #065490 | SUPPL-10 | VANCOMYCIN HYDROCHLORIDE | STRIDES PHARMA | Manufacturing (CMC) | Approval |
| May 3 | LEVOFLOXACIN ANDA #076276 | SUPPL-8 | LEVOFLOXACIN | MYLAN | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #076361 | SUPPL-13 | LEVOFLOXACIN | TEVA | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #076710 | SUPPL-14 | LEVOFLOXACIN | DR REDDYS LABS INC | Labeling | Approval |
| May 3 | CIPROFLOXACIN ANDA #076717 | SUPPL-7 | CIPROFLOXACIN | HIKMA FARMACEUTICA | Labeling | Approval |
| May 3 | CIPROFLOXACIN IN DEXTROSE 5% ANDA #076757 | SUPPL-9 | CIPROFLOXACIN | HIKMA FARMACEUTICA | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #077097 | SUPPL-8 | LEVOFLOXACIN | MYLAN | Labeling | Approval |
| May 3 | OFLOXACIN ANDA #077098 | SUPPL-12 | OFLOXACIN | DR REDDYS LABS LTD | Labeling | Approval |
| May 3 | CIPROFLOXACIN ANDA #077245 | SUPPL-23 | CIPROFLOXACIN | HOSPIRA | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #077438 | SUPPL-17 | LEVOFLOXACIN | SANDOZ | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #077652 | SUPPL-16 | LEVOFLOXACIN | ZYDUS PHARMS USA INC | Labeling | Approval |
| May 3 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077701 | SUPPL-15 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | DR REDDYS LABS LTD | Labeling | Approval |
| May 3 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077701 | SUPPL-16 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | DR REDDYS LABS LTD | Labeling | Approval |
| May 3 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #077753 | SUPPL-20 | CIPROFLOXACIN | HOSPIRA | Labeling | Approval |
| May 3 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078166 | SUPPL-14 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | ANCHEN PHARMS | Labeling | Approval |
| May 3 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078183 | SUPPL-21 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | MYLAN PHARMS INC | Labeling | Approval |
| May 3 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252 | SUPPL-32 | CIPROFLOXACIN | INFORLIFE | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #078424 | SUPPL-18 | LEVOFLOXACIN | LUPIN | Labeling | Approval |
| May 3 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078431 | SUPPL-10 | CIPROFLOXACIN | HIKMA FARMACEUTICA | Labeling | Approval |
| May 3 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078579 | SUPPL-6 | LEVOFLOXACIN | HOSPIRA INC | Labeling | Approval |
| May 3 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078712 | SUPPL-6 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | FOSUN PHARMA | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #078759 | SUPPL-3 | GEMCITABINE HYDROCHLORIDE | CIPLA | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #078759 | SUPPL-4 | GEMCITABINE HYDROCHLORIDE | CIPLA | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #078759 | SUPPL-5 | GEMCITABINE HYDROCHLORIDE | CIPLA | Labeling | Approval |
| May 3 | ROCURONIUM BROMIDE ANDA #079195 | SUPPL-17 | ROCURONIUM BROMIDE | SANDOZ INC | Labeling | Approval |
| May 3 | OGEN .625 ANDA #083220 | SUPPL-44 | ESTROPIPATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| May 3 | OGEN 1.25 ANDA #083220 | SUPPL-44 | ESTROPIPATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| May 3 | OGEN 2.5 ANDA #083220 | SUPPL-44 | ESTROPIPATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| May 3 | OGEN 5 ANDA #083220 | SUPPL-44 | ESTROPIPATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| May 3 | DEPO-ESTRADIOL ANDA #085470 | SUPPL-23 | ESTRADIOL CYPIONATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| May 3 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343 | SUPPL-27 | LEVOFLOXACIN | INFORLIFE | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #090367 | SUPPL-4 | LEVOFLOXACIN | WOCKHARDT | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #090722 | SUPPL-14 | LEVOFLOXACIN | TORRENT PHARMS | Labeling | Approval |
| May 3 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375 | SUPPL-15 | LEVOFLOXACIN | HIKMA FARMACEUTICA | Labeling | Approval |
| May 3 | KADCYLA BLA #125427 | SUPPL-105 | ADO-TRASTUZUMAB EMTANSINE | GENENTECH | Approval | |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #200145 | SUPPL-10 | GEMCITABINE HYDROCHLORIDE | MYLAN LABS LTD | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #200145 | SUPPL-11 | GEMCITABINE HYDROCHLORIDE | MYLAN LABS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200250 | SUPPL-4 | LEVOFLOXACIN | GLENMARK GENERICS | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200560 | SUPPL-13 | LEVOFLOXACIN | MYLAN ASI | Labeling | Approval |
| May 3 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #200674 | SUPPL-8 | LEVOFLOXACIN | FRESENIUS KABI USA | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200839 | SUPPL-12 | LEVOFLOXACIN | MACLEODS PHARMS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200839 | SUPPL-13 | LEVOFLOXACIN | MACLEODS PHARMS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200839 | SUPPL-17 | LEVOFLOXACIN | MACLEODS PHARMS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200839 | SUPPL-18 | LEVOFLOXACIN | MACLEODS PHARMS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #200839 | SUPPL-19 | LEVOFLOXACIN | MACLEODS PHARMS LTD | Labeling | Approval |
| May 3 | METOPROLOL TARTRATE ANDA #200981 | SUPPL-14 | METOPROLOL TARTRATE | RUBICON | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #202200 | SUPPL-8 | LEVOFLOXACIN | ORCHID HLTHCARE | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #202328 | SUPPL-10 | LEVOFLOXACIN | AUROBINDO PHARMA LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #202590 | SUPPL-10 | LEVOFLOXACIN | EMCURE PHARMS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #202801 | SUPPL-5 | LEVOFLOXACIN | HETERO LABS LTD V | Labeling | Approval |
| May 3 | OMEPRAZOLE ANDA #203270 | SUPPL-10 | OMEPRAZOLE | AUROBINDO PHARMA LTD | Manufacturing (CMC) | Approval |
| May 3 | LEVOFLOXACIN ANDA #203613 | SUPPL-4 | LEVOFLOXACIN | JUBILANT GENERICS | Labeling | Approval |
| May 3 | GANIRELIX ACETATE
ANDA #204246 | SUPPL-1 | GANIRELIX ACETATE | SUN PHARM | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #204549 | SUPPL-2 | GEMCITABINE HYDROCHLORIDE | ACTAVIS INC | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #205242 | SUPPL-1 | GEMCITABINE HYDROCHLORIDE | MYLAN LABS LTD | Labeling | Approval |
| May 3 | TRIUMEQ NDA #205551 | SUPPL-16 | ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE | VIIV HLTHCARE | Labeling | Approval |
| May 3 | MOXIFLOXACIN HYDROCHLORIDE NDA #205572 | SUPPL-6 | MOXIFLOXACIN HYDROCHLORIDE | FRESENIUS KABI USA | Labeling | Approval |
| May 3 | MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
ANDA #205833 | SUPPL-5 | MOXIFLOXACIN HYDROCHLORIDE | MYLAN LABS LTD | Labeling | Approval |
| May 3 | LEVOFLOXACIN ANDA #205968 | SUPPL-3 | LEVOFLOXACIN | ZYDUS PHARMS | Labeling | Approval |
| May 3 | ROCURONIUM BROMIDE ANDA #206206 | SUPPL-3 | ROCURONIUM BROMIDE | AUROBINDO PHARMA LTD | Labeling | Approval |
| May 3 | QUETIAPINE FUMARATE ANDA #206260 | SUPPL-2 | QUETIAPINE FUMARATE | PHARMADAX INC | Labeling | Approval |
| May 3 | GEMCITABINE HYDROCHLORIDE ANDA #206776 | SUPPL-2 | GEMCITABINE HYDROCHLORIDE | APOTEX INC | Labeling | Approval |
| May 3 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #206919 | SUPPL-5 | LEVOFLOXACIN | AUROBINDO PHARMA LTD | Labeling | Approval |
| May 3 | MELPHALAN HYDROCHLORIDE ANDA #207032 | ORIG-1 | MELPHALAN HYDROCHLORIDE | US WORLDMEDS LLC | Approval | |
| May 3 | BAXDELA NDA #208610 | SUPPL-6 | DELAFLOXACIN MEGLUMINE | MELINTA | Labeling | Approval |
| May 3 | BAXDELA NDA #208611 | SUPPL-5 | DELAFLOXACIN MEGLUMINE | MELINTA | Labeling | Approval |
| May 3 | FENTANYL CITRATE
PRESERVATIVE FREE ANDA #210762 | ORIG-1 | FENTANYL CITRATE | FRESENIUS KABI USA | Approval | |
| May 3 | VYNDAQEL NDA #211996 | ORIG-1 | TAFAMIDIS MEGLUMINE | FOLDRX PHARMACEUTICALS INC | Type 1 - New Molecular Entity | Approval |
| May 3 | VYNDAMAX NDA #212161 | ORIG-1 | TAFAMIDIS | FOLDRX PHARMACEUTICALS INC | Type 2 - New Active Ingredient | Approval |
| May 3 | FUROSEMIDE ANDA #212174 | ORIG-1 | FUROSEMIDE | AUROBINDO PHARMA LTD | Approval | |
| May 6 | SORILUX NDA #022563 | SUPPL-6 | CALCIPOTRIENE | MAYNE PHARMA | Efficacy | Approval |
| May 6 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077417 | SUPPL-8 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | ACTAVIS LABS FL INC | Labeling | Approval |
| May 6 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077809 | SUPPL-8 | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | ACTAVIS LABS FL INC | Labeling | Approval |
| May 6 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078024 | SUPPL-29 | CIPROFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078024 | SUPPL-30 | CIPROFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | CIPROFLOXACIN ANDA #078062 | SUPPL-17 | CIPROFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | CIPROFLOXACIN ANDA #078062 | SUPPL-18 | CIPROFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 1 ANDA #085055 | SUPPL-56 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 1 ANDA #085055 | SUPPL-62 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 2 ANDA #085055 | SUPPL-56 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 2 ANDA #085055 | SUPPL-62 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 3 ANDA #085055 | SUPPL-56 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 3 ANDA #085055 | SUPPL-62 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 4 ANDA #085055 | SUPPL-56 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | TYLENOL W/ CODEINE NO. 4 ANDA #085055 | SUPPL-62 | ACETAMINOPHEN; CODEINE PHOSPHATE | JANSSEN PHARMS | Labeling | Approval |
| May 6 | LEVOFLOXACIN ANDA #090787 | SUPPL-10 | LEVOFLOXACIN | APOTEX INC | Labeling | Approval |
| May 6 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091397 | SUPPL-18 | LEVOFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091397 | SUPPL-19 | LEVOFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | LEVOFLOXACIN ANDA #091436 | SUPPL-9 | LEVOFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | LEVOFLOXACIN ANDA #091436 | SUPPL-10 | LEVOFLOXACIN | BAXTER HLTHCARE CORP | Labeling | Approval |
| May 6 | ENTYVIO BLA #125476 | SUPPL-27 | VEDOLIZUMAB | TAKEDA PHARMS USA | Approval | |
| May 6 | LEVOFLOXACIN ANDA #201043 | SUPPL-18 | LEVOFLOXACIN | AUROBINDO PHARMA LTD | Labeling | Approval |
| May 6 | DICLOFENAC SODIUM ANDA #204306 | ORIG-1 | DICLOFENAC SODIUM | MYLAN | Approval | |
| May 6 | LITHIUM CARBONATE
ANDA #205532 | SUPPL-2 | LITHIUM CARBONATE | HERITAGE PHARMA | Manufacturing (CMC) | Approval |
| May 6 | RUZURGI NDA #209321 | ORIG-1 | AMIFAMPRIDINE | JACOBUS PHARMACEUTICAL CO INC | Type 2 - New Active Ingredient | Approval |
| May 6 | RUZURGI NDA #209321 | ORIG-2 | AMIFAMPRIDINE | JACOBUS PHARMACEUTICAL CO INC | Type 2 - New Active Ingredient | Tentative Approval |
| May 6 | ARSENIC TRIOXIDE ANDA #209873 | ORIG-1 | ARSENIC TRIOXIDE | STI PHARMA LLC | Approval | |
| May 6 | COLESEVELAM HYDROCHLORIDE ANDA #210316 | ORIG-1 | COLESEVELAM HYDROCHLORIDE | ALKEM LABS LTD | Approval | |
| May 6 | FOSAPREPITANT DIMEGLUMINE ANDA #210689 | ORIG-1 | FOSAPREPITANT DIMEGLUMINE | LUPIN LTD | Tentative Approval | |
| May 6 | ONPATTRO NDA #210922 | SUPPL-1 | PATISIRAN SODIUM | ALNYLAM PHARMS INC | Labeling | Approval |
| May 6 | POTASSIUM CHLORIDE ANDA #212183 | ORIG-1 | POTASSIUM CHLORIDE | BELCHER PHARMS LLC | Approval | |
| May 6 | TECENTRIQ BLA #761034 | SUPPL-13 | ATEZOLIZUMAB | GENENTECH INC | Approval | |
| May 6 | TECENTRIQ BLA #761034 | SUPPL-14 | ATEZOLIZUMAB | GENENTECH INC | Approval | |
| May 7 | NAVELBINE NDA #020388 | SUPPL-36 | VINORELBINE TARTRATE | PIERRE FABRE | Labeling | Approval |
| May 7 | CLARITIN HIVES RELIEF REDITAB NDA #020704 | SUPPL-35 | LORATADINE | BAYER HEALTHCARE LLC | Labeling | Approval |
| May 7 | CLARITIN REDITABS NDA #020704 | SUPPL-35 | LORATADINE | BAYER HEALTHCARE LLC | Labeling | Approval |
| May 7 | SUTENT NDA #021938 | SUPPL-36 | SUNITINIB MALATE | CPPI CV | Efficacy | Approval |
| May 7 | LEVOFLOXACIN ANDA #076890 | SUPPL-15 | LEVOFLOXACIN | CIPLA LTD | Labeling | Approval |
| May 7 | TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #091351 | SUPPL-2 | HYDROCHLOROTHIAZIDE; TELMISARTAN | LUPIN LTD | Labeling | Approval |
| May 7 | TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #091351 | SUPPL-4 | HYDROCHLOROTHIAZIDE; TELMISARTAN | LUPIN LTD | Labeling | Approval |
| May 7 | LOSARTAN POTASSIUM ANDA #091541 | SUPPL-12 | LOSARTAN POTASSIUM | MICRO LABS | Labeling | Approval |
| May 7 | ENTYVIO BLA #125476 | SUPPL-24 | VEDOLIZUMAB | TAKEDA PHARMS USA | Approval | |
| May 7 | TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #201192 | SUPPL-6 | HYDROCHLOROTHIAZIDE; TELMISARTAN | TORRENT | Labeling | Approval |
| May 7 | TELMISARTAN AND AMLODIPINE ANDA #201586 | SUPPL-6 | AMLODIPINE BESYLATE; TELMISARTAN | LUPIN LTD | Labeling | Approval |
| May 7 | LOSARTAN POTASSIUM ANDA #203030 | SUPPL-4 | LOSARTAN POTASSIUM | UNICHEM LABS LTD | Labeling | Approval |
| May 7 | DESVENLAFAXINE SUCCINATE ANDA #204805 | ORIG-1 | DESVENLAFAXINE SUCCINATE | INTELLIPHARMACEUTICS | Approval | |
| May 7 | POTASSIUM CHLORIDE NDA #206814 | SUPPL-8 | POTASSIUM CHLORIDE | GENUS LIFESCIENCES | Manufacturing (CMC) | Approval |
| May 7 | ROSUVASTATIN CALCIUM ANDA #207375 | ORIG-1 | ROSUVASTATIN CALCIUM | SHANDONG | Approval | |
| May 7 | PENICILLAMINE ANDA #209921 | ORIG-1 | PENICILLAMINE | AMERIGEN PHARMS LTD | Approval | |
| May 7 | BUSULFAN ANDA #210448 | ORIG-1 | BUSULFAN | APOTEX INC | Approval | |
| May 8 | DECADRON NDA #011664 | SUPPL-64 | DEXAMETHASONE | MERCK | Labeling | Approval |
| May 8 | LO/OVRAL-28 NDA #017802 | SUPPL-34 | ETHINYL ESTRADIOL; NORGESTREL | WYETH PHARMS | Labeling | Approval |
| May 8 | NORMINEST FE NDA #017948 | SUPPL-46 | ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE | GD SEARLE LLC | Labeling | Approval |
| May 8 | NORQUEST FE NDA #018926 | SUPPL-13 | ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE | GD SEARLE LLC | Labeling | Approval |
| May 8 | TRIPHASIL-28 NDA #019190 | SUPPL-49 | ETHINYL ESTRADIOL; LEVONORGESTREL | WYETH PHARMS INC | Labeling | Approval |
| May 8 | TRIPHASIL-21 NDA #019192 | SUPPL-48 | ETHINYL ESTRADIOL; LEVONORGESTREL | WYETH PHARMS | Labeling | Approval |
| May 8 | NUVARING NDA #021187 | SUPPL-37 | ETHINYL ESTRADIOL; ETONOGESTREL | ORGANON SUB MERCK | Labeling | Approval |
| May 8 | OMNARIS NDA #022004 | SUPPL-18 | CICLESONIDE | COVIS PHARMA BV | Labeling | Approval |
| May 8 | BETHANECHOL CHLORIDE ANDA #040725 | SUPPL-2 | BETHANECHOL CHLORIDE | ECI PHARMS LLC | Manufacturing (CMC) | Approval |
| May 8 | BETHANECHOL CHLORIDE ANDA #040726 | SUPPL-2 | BETHANECHOL CHLORIDE | ECI PHARMS LLC | Manufacturing (CMC) | Approval |
| May 8 | BETHANECHOL CHLORIDE ANDA #040727 | SUPPL-2 | BETHANECHOL CHLORIDE | ECI PHARMS LLC | Manufacturing (CMC) | Approval |
| May 8 | BETHANECHOL CHLORIDE ANDA #040728 | SUPPL-2 | BETHANECHOL CHLORIDE | ECI PHARMS LLC | Manufacturing (CMC) | Approval |
| May 8 | PROLIA BLA #125320 | SUPPL-196 | DENOSUMAB | AMGEN | Approval | |
| May 8 | PROLIA BLA #125320 | SUPPL-199 | DENOSUMAB | AMGEN | Approval | |
| May 8 | XGEVA BLA #125320 | SUPPL-196 | DENOSUMAB | AMGEN | Approval | |
| May 8 | XGEVA BLA #125320 | SUPPL-199 | DENOSUMAB | AMGEN | Approval | |
| May 8 | YERVOY BLA #125377 | SUPPL-102 | IPILIMUMAB | BRISTOL MYERS SQUIBB | Approval | |
| May 8 | ESZOPICLONE ANDA #203087 | ORIG-1 | ESZOPICLONE | BRECKENRIDGE PHARM | Approval | |
| May 8 | BUSULFAN ANDA #207050 | SUPPL-1 | BUSULFAN | PHARMASCIENCE INC | Labeling | Approval |
| May 8 | BUSULFAN ANDA #207050 | SUPPL-2 | BUSULFAN | PHARMASCIENCE INC | Labeling | Approval |
| May 8 | DAPSONE ANDA #207165 | ORIG-1 | DAPSONE | SAI LIFE SCIENCES | Approval | |
| May 9 | CREON NDA #020725 | SUPPL-25 | PANCRELIPASE (AMYLASE; LIPASE; PROTEASE) | ABBVIE | Labeling | Approval |
| May 9 | LANTUS NDA #021081 | SUPPL-72 | INSULIN GLARGINE RECOMBINANT | SANOFI AVENTIS US | Labeling | Approval |
| May 9 | LANTUS SOLOSTAR NDA #021081 | SUPPL-72 | INSULIN GLARGINE RECOMBINANT | SANOFI AVENTIS US | Labeling | Approval |
| May 9 | ARMODAFINIL ANDA #200043 | ORIG-2 | ARMODAFINIL | MYLAN PHARMS INC | Approval | |
| May 9 | MESALAMINE ANDA #207873 | ORIG-1 | MESALAMINE | TEVA PHARMS USA | Approval | |
| May 9 | LACOSAMIDE ANDA #209301 | ORIG-1 | LACOSAMIDE | HETERO LABS UNIT III | Tentative Approval | |
| May 9 | HYDROXYPROGESTERONE CAPROATE ANDA #211142 | ORIG-1 | HYDROXYPROGESTERONE CAPROATE | EUGIA PHARMA | Approval | |
| May 9 | SPRAVATO NDA #211243 | SUPPL-1 | ESKETAMINE HYDROCHLORIDE | JANSSEN PHARMS | Labeling | Approval |
| May 10 | ANAFRANIL NDA #019906 | SUPPL-43 | CLOMIPRAMINE HYDROCHLORIDE | SPECGX LLC | Labeling | Approval |
| May 10 | EPIVIR NDA #020564 | SUPPL-39 | LAMIVUDINE | VIIV HLTHCARE | Labeling | Approval |
| May 10 | EPIVIR NDA #020596 | SUPPL-38 | LAMIVUDINE | VIIV HLTHCARE | Labeling | Approval |
| May 10 | COMBIVIR NDA #020857 | SUPPL-34 | LAMIVUDINE; ZIDOVUDINE | VIIV HLTHCARE | Labeling | Approval |
| May 10 | ANDROGEL NDA #021015 | SUPPL-45 | TESTOSTERONE | ABBVIE | Labeling | Approval |
| May 10 | TRIZIVIR NDA #021205 | SUPPL-38 | ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE | VIIV HLTHCARE | Labeling | Approval |
| May 10 | TESTIM NDA #021454 | SUPPL-27 | TESTOSTERONE | AUXILIUM PHARMS LLC | Labeling | Approval |
| May 10 | FORTESTA NDA #021463 | SUPPL-20 | TESTOSTERONE | ENDO PHARMS | Labeling | Approval |
| May 10 | CADUET NDA #021540 | SUPPL-44 | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | PFIZER | Labeling | Approval |
| May 10 | EPZICOM NDA #021652 | SUPPL-24 | ABACAVIR SULFATE; LAMIVUDINE | VIIV HLTHCARE | Labeling | Approval |
| May 10 | ANDROGEL NDA #022309 | SUPPL-20 | TESTOSTERONE | ABBVIE | Labeling | Approval |
| May 10 | ZOSYN NDA #050684 | SUPPL-94 | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | WYETH PHARMS | Labeling | Approval |
| May 10 | ZOSYN IN PLASTIC CONTAINER
NDA #050750 | SUPPL-41 | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | WYETH PHARMS | Labeling | Approval |
| May 10 | LANSOPRAZOLE ANDA #091269 | SUPPL-8 | LANSOPRAZOLE | DR REDDYS LABS LTD | Labeling | Approval |
| May 10 | LANSOPRAZOLE ANDA #091269 | SUPPL-12 | LANSOPRAZOLE | DR REDDYS LABS LTD | Labeling | Approval |
| May 10 | LANSOPRAZOLE ANDA #091269 | SUPPL-13 | LANSOPRAZOLE | DR REDDYS LABS LTD | Labeling | Approval |
| May 10 | LANSOPRAZOLE ANDA #091269 | SUPPL-14 | LANSOPRAZOLE | DR REDDYS LABS LTD | Labeling | Approval |
| May 10 | LANSOPRAZOLE ANDA #091269 | SUPPL-16 | LANSOPRAZOLE | DR REDDYS LABS LTD | Labeling | Approval |
| May 10 | Xeomin BLA #125360 | SUPPL-74 | incobotulinumtoxinA | MERZ PHARMS | Approval | |
| May 10 | CYRAMZA BLA #125477 | SUPPL-29 | RAMUCIRUMAB | ELI LILLY AND CO | Approval | |
| May 10 | LANSOPRAZOLE ANDA #202176 | SUPPL-7 | LANSOPRAZOLE | WOCKHARDT USA | Labeling | Approval |
| May 10 | LANSOPRAZOLE ANDA #202176 | SUPPL-8 | LANSOPRAZOLE | WOCKHARDT USA | Labeling | Approval |
| May 10 | TESTOSTERONE ANDA #204255 | SUPPL-4 | TESTOSTERONE | PERRIGO ISRAEL | Labeling | Approval |
| May 10 | VOGELXO NDA #204399 | SUPPL-10 | TESTOSTERONE | UPSHER SMITH LABS | Labeling | Approval |
| May 10 | TESTOSTERONE ANDA #205328 | SUPPL-1 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| May 10 | SAPROPTERIN DIHYDROCHLORIDE ANDA #207200 | ORIG-1 | SAPROPTERIN DIHYDROCHLORIDE | PAR PHARM INC | Approval | |
| May 10 | NUPLAZID NDA #207318 | SUPPL-7 | PIMAVANSERIN TARTRATE | ACADIA PHARMS INC | Labeling | Approval |
| May 10 | CHLORTHALIDONE ANDA #207813 | ORIG-1 | CHLORTHALIDONE | ZYDUS PHARMS | Approval | |
| May 10 | TESTOSTERONE ANDA #208061 | SUPPL-1 | TESTOSTERONE | LUPIN LTD | Labeling | Approval |
| May 10 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE ANDA #208499 | ORIG-1 | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | PERRIGO R AND D | Approval | |
| May 10 | ESOMEPRAZOLE MAGNESIUM ANDA #209495 | ORIG-1 | ESOMEPRAZOLE MAGNESIUM | GLENMARK PHARMS | Approval | |
| May 10 | TESTOSTERONE ANDA #209533 | SUPPL-3 | TESTOSTERONE | CIPLA | Labeling | Approval |
| May 10 | NUPLAZID NDA #210793 | SUPPL-2 | PIMAVANSERIN TARTRATE | ACADIA PHARMS INC | Labeling | Approval |
| May 10 | DEXAMETHASONE SODIUM PHOSPHATE ANDA #211036 | ORIG-1 | DEXAMETHASONE SODIUM PHOSPHATE | SOMERSET THERAPS LLC | Approval | |
| May 10 | OXYBUTYNIN CHLORIDE ANDA #211682 | ORIG-1 | OXYBUTYNIN CHLORIDE | EMCURE PHARMS LTD | Approval | |
| May 13 | ALEVE NDA #020204 | SUPPL-63 | NAPROXEN SODIUM | BAYER | Labeling | Approval |
| May 13 | ALEVE NDA #020204 | SUPPL-64 | NAPROXEN SODIUM | BAYER | Labeling | Approval |
| May 13 | ALEVE NDA #020204 | SUPPL-65 | NAPROXEN SODIUM | BAYER | Labeling | Approval |
| May 13 | EYLEA BLA #125387 | SUPPL-61 | AFLIBERCEPT | REGENERON PHARMACEUTICALS | Approval | |
| May 13 | ENTECAVIR ANDA #202122 | SUPPL-3 | ENTECAVIR | TEVA PHARMS USA | Labeling | Approval |
| May 13 | ENTECAVIR ANDA #202122 | SUPPL-5 | ENTECAVIR | TEVA PHARMS USA | Labeling | Approval |
| May 13 | ENTECAVIR ANDA #202122 | SUPPL-7 | ENTECAVIR | TEVA PHARMS USA | Labeling | Approval |
| May 13 | ODOMZO NDA #205266 | SUPPL-6 | SONIDEGIB PHOSPHATE | SUN PHARMA GLOBAL | Labeling | Approval |
| May 13 | RISEDRONATE SODIUM ANDA #205280 | ORIG-1 | RISEDRONATE SODIUM | ORCHID HLTHCARE | Approval | |
| May 13 | DOXORUBICIN HYDROCHLORIDE ANDA #206062 | ORIG-1 | DOXORUBICIN HYDROCHLORIDE | HISUN PHARM HANGZHOU | Approval | |
| May 13 | CORLANOR NDA #206143 | SUPPL-7 | IVABRADINE HYDROCHLORIDE | AMGEN INC | Labeling | Approval |
| May 13 | ENTECAVIR ANDA #206872 | SUPPL-2 | ENTECAVIR | CIPLA | Labeling | Approval |
| May 13 | ENTECAVIR ANDA #206872 | SUPPL-3 | ENTECAVIR | CIPLA | Labeling | Approval |
| May 13 | ENTECAVIR ANDA #208721 | SUPPL-1 | ENTECAVIR | BRECKENRIDGE PHARM | Labeling | Approval |
| May 13 | FENOFIBRATE (MICRONIZED)
ANDA #209504 | SUPPL-2 | FENOFIBRATE | AMERIGEN PHARMS LTD | Labeling | Approval |
| May 13 | LABETALOL HYDROCHLORIDE ANDA #211325 | ORIG-1 | LABETALOL HYDROCHLORIDE | CADILA PHARMS LTD | Approval | |
| May 13 | NEOSTIGMINE METHYLSULFATE ANDA #212512 | ORIG-1 | NEOSTIGMINE METHYLSULFATE | BE PHARMS | Approval | |
| May 14 | GEMZAR NDA #020509 | SUPPL-82 | GEMCITABINE HYDROCHLORIDE | LILLY | Labeling | Approval |
| May 14 | EDURANT NDA #202022 | SUPPL-13 | RILPIVIRINE HYDROCHLORIDE | JANSSEN PRODS | Labeling | Approval |
| May 14 | VASOSTRICT NDA #204485 | SUPPL-9 | VASOPRESSIN | PAR STERILE PRODUCTS | Labeling | Approval |
| May 14 | FULVESTRANT ANDA #205935 | ORIG-1 | FULVESTRANT | SANDOZ INC | Approval | |
| May 14 | ALBENDAZOLE ANDA #211117 | ORIG-1 | ALBENDAZOLE | EDENBRIDGE PHARMS | Approval | |
| May 14 | GLYCOPYRROLATE ANDA #211334 | ORIG-1 | GLYCOPYRROLATE | SANDOZ INC | Approval | |
| May 14 | BAVENCIO BLA #761049 | SUPPL-6 | AVELUMAB | EMD SERONO INC | Approval | |
| May 15 | TRIGLIDE NDA #021350 | SUPPL-22 | FENOFIBRATE | SKYEPHARMA AG | Labeling | Approval |
| May 15 | LIPOFEN NDA #021612 | SUPPL-20 | FENOFIBRATE | CIPHER PHARMS INC | Labeling | Approval |
| May 15 | ANTARA (MICRONIZED) NDA #021695 | SUPPL-20 | FENOFIBRATE | LUPIN ATLANTIS | Labeling | Approval |
| May 15 | FENOGLIDE NDA #022118 | SUPPL-10 | FENOFIBRATE | SALIX | Labeling | Approval |
| May 15 | FIBRICOR NDA #022418 | SUPPL-15 | FENOFIBRIC ACID | ATHENA | Labeling | Approval |
| May 15 | ALLOPURINOL ANDA #071450 | SUPPL-40 | ALLOPURINOL | SUN PHARM INDUSTRIES | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #075753 | SUPPL-10 | FENOFIBRATE | RHODES PHARMS | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #075868 | SUPPL-20 | FENOFIBRATE | IMPAX LABS | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #202676 | SUPPL-5 | FENOFIBRATE | MYLAN PHARMS INC | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #205566 | SUPPL-3 | FENOFIBRATE | GLENMARK PHARMS LTD | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #207378 | SUPPL-4 | FENOFIBRATE | INVAGEN PHARMS | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #207805 | SUPPL-8 | FENOFIBRATE | AUSTARPHARMA | Labeling | Approval |
| May 15 | ZOLEDRONIC ACID ANDA #208513 | ORIG-1 | ZOLEDRONIC ACID | SHILPA MEDICARE LTD | Approval | |
| May 15 | VENCLEXTA NDA #208573 | SUPPL-13 | VENETOCLAX | ABBVIE INC | Efficacy | Approval |
| May 15 | TRELEGY ELLIPTA NDA #209482 | SUPPL-5 | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | GLAXOSMITHKLINE | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #209504 | SUPPL-4 | FENOFIBRATE | AMERIGEN PHARMS LTD | Labeling | Approval |
| May 15 | IBUPROFEN ANDA #210149 | SUPPL-1 | IBUPROFEN | GUARDIAN DRUG | Manufacturing (CMC) | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #210705 | SUPPL-1 | FENOFIBRATE | AJANTA PHARMA LTD | Labeling | Approval |
| May 15 | FENOFIBRATE (MICRONIZED) ANDA #210782 | SUPPL-1 | FENOFIBRATE | TORRENT | Labeling | Approval |
| May 16 | FRAGMIN NDA #020287 | SUPPL-72 | DALTEPARIN SODIUM | PFIZER INC | Efficacy | Approval |
| May 16 | AGGRASTAT NDA #020912 | SUPPL-27 | TIROFIBAN HYDROCHLORIDE | MEDICURE | Labeling | Approval |
| May 16 | AGGRASTAT NDA #020913 | SUPPL-26 | TIROFIBAN HYDROCHLORIDE | MEDICURE | Labeling | Approval |
| May 16 | TRACLEER NDA #021290 | SUPPL-39 | BOSENTAN | ACTELION PHARMS LTD | Labeling | Approval |
| May 16 | LIVALO NDA #022363 | SUPPL-15 | PITAVASTATIN CALCIUM | KOWA CO | Efficacy | Approval |
| May 16 | GATTEX KIT NDA #203441 | SUPPL-13 | TEDUGLUTIDE RECOMBINANT | NPS PHARMS INC | Efficacy | Approval |
| May 16 | TESTOSTERONE ANDA #204570 | SUPPL-1 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| May 16 | CABAZITAXEL ANDA #207381 | ORIG-1 | CABAZITAXEL | MYLAN LABS LTD | Tentative Approval | |
| May 16 | RIVAROXABAN ANDA #208549 | ORIG-1 | RIVAROXABAN | PRINSTON INC | Tentative Approval | |
| May 16 | TRACLEER NDA #209279 | SUPPL-5 | BOSENTAN | ACTELION PHARMS | Labeling | Approval |
| May 16 | JORNAY PM NDA #209311 | SUPPL-3 | METHYLPHENIDATE HYDROCHLORIDE | IRONSHORE PHARMS | Labeling | Approval |
| May 16 | DOCETAXEL ANDA #210327 | ORIG-1 | DOCETAXEL | SHILPA MEDICARE LTD | Approval | |
| May 16 | DOLUTEGRAVIR ANDA #210963 | ORIG-1 | DOLUTEGRAVIR | LAURUS LABS LTD | Tentative Approval | |
| May 16 | DICLOFENAC SODIUM ANDA #211253 | ORIG-1 | DICLOFENAC SODIUM | GAGE DEVELOPMENT | Approval | |
| May 16 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ANDA #212266 | ORIG-1 | CETIRIZINE HYDROCHLORIDE | QUAGEN | Approval | |
| May 16 | HERZUMA BLA #761091 | SUPPL-1 | TRASTUZUMAB-PKRB | CELLTRION INC | Approval | |
| May 16 | HERZUMA BLA #761091 | SUPPL-2 | TRASTUZUMAB-PKRB | CELLTRION INC | Approval | |
| May 17 | PLAVIX NDA #020839 | SUPPL-72 | CLOPIDOGREL BISULFATE | SANOFI AVENTIS US | Labeling | Approval |
| May 17 | ORFADIN NDA #021232 | SUPPL-23 | NITISINONE | SWEDISH ORPHAN | Labeling | Approval |
| May 17 | SUMATRIPTAN SUCCINATE ANDA #078295 | SUPPL-8 | SUMATRIPTAN SUCCINATE | SUN PHARM INDS | Labeling | Approval |
| May 17 | SUMATRIPTAN SUCCINATE ANDA #078327 | SUPPL-11 | SUMATRIPTAN SUCCINATE | AUROBINDO PHARMA | Labeling | Approval |
| May 17 | IMIPENEM AND CILASTATIN ANDA #090825 | SUPPL-11 | CILASTATIN SODIUM; IMIPENEM | HOSPIRA INC | Labeling | Approval |
| May 17 | IMIPENEM AND CILASTATIN ANDA #090825 | SUPPL-12 | CILASTATIN SODIUM; IMIPENEM | HOSPIRA INC | Labeling | Approval |
| May 17 | AZELASTINE HYDROCHLORIDE ANDA #091444 | SUPPL-3 | AZELASTINE HYDROCHLORIDE | WEST-WARD PHARMS INT | Labeling | Approval |
| May 17 | PROLEUKIN BLA #103293 | SUPPL-5146 | ALDESLEUKIN | CHIRON | Approval | |
| May 17 | TELMISARTAN ANDA #202397 | SUPPL-6 | TELMISARTAN | MYLAN | Labeling | Approval |
| May 17 | TELMISARTAN ANDA #203867 | SUPPL-7 | TELMISARTAN | SANDOZ INC | Labeling | Approval |
| May 17 | MELPHALAN HYDROCHLORIDE ANDA #204817 | ORIG-1 | MELPHALAN HYDROCHLORIDE | ALVOGEN INC | Approval | |
| May 17 | ORFADIN NDA #206356 | SUPPL-6 | NITISINONE | SWEDISH ORPHAN | Labeling | Approval |
| May 17 | MICAFUNGIN SODIUM ANDA #207344 | ORIG-1 | MICAFUNGIN SODIUM | FRESENIUS KABI USA | Approval | |
| May 17 | AZELASTINE HYDROCHLORIDE ANDA #207610 | ORIG-1 | AZELASTINE HYDROCHLORIDE | HI TECH | Approval | |
| May 17 | LURASIDONE HYDROCHLORIDE ANDA #208060 | ORIG-1 | LURASIDONE HYDROCHLORIDE | TEVA PHARMS USA | Approval | |
| May 17 | TELMISARTAN ANDA #208605 | SUPPL-1 | TELMISARTAN | CADILA PHARMS LTD | Labeling | Approval |
| May 17 | CINACALCET HYDROCHLORIDE ANDA #210570 | ORIG-1 | CINACALCET HYDROCHLORIDE | ALKEM LABS LTD | Approval | |
| May 17 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #210651 | ORIG-1 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | RHODES PHARMS | Approval | |
| May 17 | NAYZILAM NDA #211321 | ORIG-1 | MIDAZOLAM | PROXIMAGEN LLC | Type 3 - New Dosage Form | Approval |
| May 17 | ZULRESSO NDA #211371 | SUPPL-1 | BREXANOLONE | SAGE THERAPEUTICS | REMS | Approval |
| May 17 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #211715 | ORIG-1 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | SUN PHARM INDUSTRIES | Approval | |
| May 19 | MOMETASONE FUROATE ANDA #076624 | SUPPL-8 | MOMETASONE FUROATE | TARO | Labeling | Approval |
| May 19 | BENAZEPRIL HYDROCHLORIDE ANDA #076820 | SUPPL-18 | BENAZEPRIL HYDROCHLORIDE | AMNEAL PHARMS | Labeling | Approval |
| May 19 | LETROZOLE ANDA #090289 | SUPPL-4 | LETROZOLE | TEVA PHARMS | Labeling | Approval |
| May 19 | LETROZOLE ANDA #090289 | SUPPL-5 | LETROZOLE | TEVA PHARMS | Labeling | Approval |
| May 19 | LETROZOLE ANDA #091303 | SUPPL-2 | LETROZOLE | APOTEX INC | Labeling | Approval |
| May 19 | LETROZOLE ANDA #091303 | SUPPL-3 | LETROZOLE | APOTEX INC | Labeling | Approval |
| May 19 | LETROZOLE ANDA #202716 | SUPPL-2 | LETROZOLE | JIANGSU HENGRUI MED | Labeling | Approval |
| May 19 | LETROZOLE ANDA #202716 | SUPPL-3 | LETROZOLE | JIANGSU HENGRUI MED | Labeling | Approval |
| May 20 | APOKYN NDA #021264 | SUPPL-16 | APOMORPHINE HYDROCHLORIDE | US WORLDMEDS | Labeling | Approval |
| May 20 | FASLODEX NDA #021344 | SUPPL-39 | FULVESTRANT | ASTRAZENECA | Labeling | Approval |
| May 20 | PEMETREXED ANDA #090352 | ORIG-1 | PEMETREXED SODIUM | TEVA PHARMS USA | Tentative Approval | |
| May 20 | DONEPEZIL HYDROCHLORIDE ANDA #090686 | SUPPL-12 | DONEPEZIL HYDROCHLORIDE | TORRENT PHARMS | Labeling | Approval |
| May 20 | SOLIFENACIN SUCCINATE ANDA #202551 | ORIG-1 | SOLIFENACIN SUCCINATE | WATSON LABS INC | Approval | |
| May 20 | DONEPEZIL HYDROCHLORIDE ANDA #203656 | SUPPL-1 | DONEPEZIL HYDROCHLORIDE | UNICHEM LABS LTD | Labeling | Approval |
| May 20 | DACTINOMYCIN ANDA #203999 | ORIG-1 | DACTINOMYCIN | X-GEN PHARMS INC | Approval | |
| May 20 | DONEPEZIL HYDROCHLORIDE ANDA #204609 | SUPPL-2 | DONEPEZIL HYDROCHLORIDE | CADILA PHARMS LTD | Labeling | Approval |
| May 20 | SOLIFENACIN SUCCINATE ANDA #205483 | ORIG-1 | SOLIFENACIN SUCCINATE | AJANTA PHARMA LTD | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #205575 | ORIG-1 | SOLIFENACIN SUCCINATE | ALEMBIC PHARMS LTD | Approval | |
| May 20 | ALBENDAZOLE ANDA #208094 | ORIG-1 | ALBENDAZOLE | ACTAVIS ELIZABETH | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #209239 | ORIG-1 | SOLIFENACIN SUCCINATE | GLENMARK PHARMS INC | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #209333 | ORIG-1 | SOLIFENACIN SUCCINATE | QILU PHARM CO LTD | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #209719 | ORIG-1 | SOLIFENACIN SUCCINATE | AMNEAL PHARMS CO | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #209818 | ORIG-1 | SOLIFENACIN SUCCINATE | BRECKENRIDGE PHARM | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #209839 | ORIG-1 | SOLIFENACIN SUCCINATE | CIPLA | Approval | |
| May 20 | METHYLPREDNISOLONE ACETATE ANDA #210043 | ORIG-1 | METHYLPREDNISOLONE ACETATE | AMNEAL PHARMS CO | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #210224 | ORIG-1 | SOLIFENACIN SUCCINATE | ALKEM LABS LTD | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #210281 | ORIG-1 | SOLIFENACIN SUCCINATE | JIANGXI BOYA SEEHOT | Approval | |
| May 20 | FULVESTRANT NDA #210326 | ORIG-1 | FULVESTRANT | FRESENIUS KABI USA | Type 5 - New Formulation or New Manufacturer | Approval |
| May 20 | DIMETHYL FUMARATE ANDA #210492 | ORIG-1 | DIMETHYL FUMARATE | SUN PHARM INDS LTD | Tentative Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #210582 | ORIG-1 | SOLIFENACIN SUCCINATE | CELLTRION | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #210688 | ORIG-1 | SOLIFENACIN SUCCINATE | MSN LABS PVT LTD | Approval | |
| May 20 | SOLIFENACIN SUCCINATE ANDA #211657 | ORIG-1 | SOLIFENACIN SUCCINATE | SCIEGEN PHARMS INC | Approval | |
| May 21 | WELCHOL NDA #021176 | SUPPL-45 | COLESEVELAM HYDROCHLORIDE | DAIICHI SANKYO | Labeling | Approval |
| May 21 | WELCHOL NDA #022362 | SUPPL-25 | COLESEVELAM HYDROCHLORIDE | DAIICHI SANKYO | Labeling | Approval |
| May 21 | CLEOCIN NDA #050680 | SUPPL-17 | CLINDAMYCIN PHOSPHATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| May 21 | DONEPEZIL HYDROCHLORIDE ANDA #077518 | SUPPL-2 | DONEPEZIL HYDROCHLORIDE | CIPLA LTD | Labeling | Approval |
| May 21 | DONEPEZIL HYDROCHLORIDE ANDA #090056 | SUPPL-10 | DONEPEZIL HYDROCHLORIDE | AUROBINDO | Labeling | Approval |
| May 21 | DONEPEZIL HYDROCHLORIDE ANDA #090290 | SUPPL-9 | DONEPEZIL HYDROCHLORIDE | SANDOZ | Labeling | Approval |
| May 21 | DONEPEZIL HYDROCHLORIDE ANDA #201724 | SUPPL-5 | DONEPEZIL HYDROCHLORIDE | ALEMBIC PHARMS LTD | Labeling | Approval |
| May 21 | LOSARTAN POTASSIUM ANDA #202230 | SUPPL-10 | LOSARTAN POTASSIUM | MACLEODS PHARMS LTD | Labeling | Approval |
| May 21 | DONEPEZIL HYDROCHLORIDE ANDA #202723 | SUPPL-4 | DONEPEZIL HYDROCHLORIDE | DR REDDYS | Labeling | Approval |
| May 21 | DONEPEZIL HYDROCHLORIDE ANDA #202723 | SUPPL-5 | DONEPEZIL HYDROCHLORIDE | DR REDDYS | Labeling | Approval |
| May 21 | PARICALCITOL ANDA #206699 | SUPPL-1 | PARICALCITOL | AMNEAL PHARMS CO | Labeling | Approval |
| May 21 | DALFAMPRIDINE ANDA #208292 | ORIG-1 | DALFAMPRIDINE | SUN PHARM | Approval | |
| May 21 | YUPELRI NDA #210598 | SUPPL-1 | REVEFENACIN | MYLAN IRELAND LTD | Labeling | Approval |
| May 22 | SOTRADECOL ANDA #040541 | SUPPL-15 | SODIUM TETRADECYL SULFATE | MYLAN INSTITUTIONAL | Labeling | Approval |
| May 22 | OFLOXACIN ANDA #076093 | SUPPL-11 | OFLOXACIN | LARKEN LABS | Labeling | Approval |
| May 22 | SUMATRIPTAN SUCCINATE ANDA #090358 | SUPPL-15 | SUMATRIPTAN SUCCINATE | SUN PHARM | Labeling | Approval |
| May 22 | DULOXETINE HYDROCHLORIDE ANDA #090739 | SUPPL-13 | DULOXETINE HYDROCHLORIDE | ZYDUS HLTHCARE | Labeling | Approval |
| May 22 | LEVOFLOXACIN ANDA #091678 | SUPPL-4 | LEVOFLOXACIN | HI TECH PHARMA | Labeling | Approval |
| May 22 | DECITABINE NDA #205582 | SUPPL-9 | DECITABINE | SUN PHARMA GLOBAL | Labeling | Approval |
| May 22 | ESOMEPRAZOLE MAGNESIUM ANDA #206296 | ORIG-1 | ESOMEPRAZOLE MAGNESIUM | ZYDUS PHARMS | Approval | |
| May 22 | GEMCITABINE HYDROCHLORIDE ANDA #206776 | SUPPL-3 | GEMCITABINE HYDROCHLORIDE | APOTEX INC | Labeling | Approval |
| May 22 | PHYTONADIONE ANDA #207719 | ORIG-1 | PHYTONADIONE | DR REDDYS LABS LTD | Approval | |
| May 22 | SIKLOS NDA #208843 | SUPPL-2 | HYDROXYUREA | ADDMEDICA SAS | Labeling | Approval |
| May 22 | EPIDIOLEX NDA #210365 | SUPPL-4 | CANNABIDIOL | GW RES LTD | Manufacturing (CMC) | Approval |
| May 22 | ERLOTINIB ANDA #211083 | ORIG-1 | ERLOTINIB | ACCORD HLTHCARE INC | Tentative Approval | |
| May 22 | TRIENTINE HYDROCHLORIDE
ANDA #211134 | ORIG-1 | TRIENTINE HYDROCHLORIDE | MSN LABS PVT LTD | Approval | |
| May 22 | CYPROHEPTADINE HYDROCHLORIDE ANDA #212423 | ORIG-1 | CYPROHEPTADINE HYDROCHLORIDE | QUAGEN | Approval | |
| May 23 | LYRICA NDA #021446 | SUPPL-36 | PREGABALIN | PF PRISM CV | Efficacy | Approval |
| May 23 | LYRICA NDA #022488 | SUPPL-14 | PREGABALIN | PF PRISM CV | Efficacy | Approval |
| May 23 | LEVOFLOXACIN ANDA #091678 | SUPPL-6 | LEVOFLOXACIN | HI TECH PHARMA | Labeling | Approval |
| May 23 | ENSKYCE ANDA #201887 | SUPPL-8 | DESOGESTREL; ETHINYL ESTRADIOL | LUPIN LTD | Labeling | Approval |
| May 23 | ENSKYCE ANDA #201887 | SUPPL-10 | DESOGESTREL; ETHINYL ESTRADIOL | LUPIN LTD | Labeling | Approval |
| May 23 | ENSKYCE ANDA #201887 | SUPPL-13 | DESOGESTREL; ETHINYL ESTRADIOL | LUPIN LTD | Manufacturing (CMC) | Approval |
| May 23 | FLUOXETINE HYDROCHLORIDE ANDA #206993 | ORIG-1 | FLUOXETINE HYDROCHLORIDE | CADILA PHARMS LTD | Approval | |
| May 23 | PEMETREXED SODIUM ANDA #208262 | ORIG-1 | PEMETREXED SODIUM | WOCKHARDT BIO AG | Tentative Approval | |
| May 23 | POTASSIUM CHLORIDE ANDA #210902 | ORIG-1 | POTASSIUM CHLORIDE | AMNEAL PHARMS LLC | Approval | |
| May 23 | PEMETREXED DISODIUM NDA #211090 | ORIG-1 | PEMETREXED DISODIUM | BIOCON PHARMA LTD | Tentative Approval | |
| May 23 | SLYND NDA #211367 | ORIG-1 | DROSPIRENONE | EXELTIS USA INC | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | Approval |
| May 23 | METHYLPHENIDATE HYDROCHLORIDE ANDA #211796 | ORIG-1 | METHYLPHENIDATE HYDROCHLORIDE | GRANULES PHARMS | Approval | |
| May 23 | CLOBAZAM ANDA #212398 | ORIG-1 | CLOBAZAM | ACCORD HLTHCARE | Approval | |
| May 23 | TRUXIMA BLA #761088 | SUPPL-1 | RITUXIMAB-ABBS | CELLTRION INC | Approval | |
| May 23 | TRUXIMA BLA #761088 | SUPPL-2 | RITUXIMAB-ABBS | CELLTRION INC | Approval | |
| May 24 | DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020201 | SUPPL-40 | DOBUTAMINE HYDROCHLORIDE | HOSPIRA | Labeling | Approval |
| May 24 | EXJADE NDA #021882 | SUPPL-31 | DEFERASIROX | NOVARTIS | Efficacy | Approval |
| May 24 | OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078394 | SUPPL-14 | IBUPROFEN; OXYCODONE
HYDROCHLORIDE | WATSON LABS | Labeling | Approval |
| May 24 | CALCIPOTRIENE ANDA #090633 | SUPPL-5 | CALCIPOTRIENE | GLENMARK PHARMS INC | Labeling | Approval |
| May 24 | CALCIPOTRIENE ANDA #090633 | SUPPL-6 | CALCIPOTRIENE | GLENMARK PHARMS INC | Labeling | Approval |
| May 24 | PROLIA BLA #125320 | SUPPL-195 | DENOSUMAB | AMGEN | Approval | |
| May 24 | XGEVA BLA #125320 | SUPPL-195 | DENOSUMAB | AMGEN | Approval | |
| May 24 | METOCLOPRAMIDE HYDROCHLORIDE ANDA #202191 | SUPPL-5 | METOCLOPRAMIDE HYDROCHLORIDE | NOVEL LABS INC | Labeling | Approval |
| May 24 | JAKAFI NDA #202192 | SUPPL-17 | RUXOLITINIB PHOSPHATE | INCYTE CORP | Efficacy | Approval |
| May 24 | VRAYLAR NDA #204370 | SUPPL-6 | CARIPRAZINE HYDROCHLORIDE | ALLERGAN SALES LLC | Efficacy | Approval |
| May 24 | JADENU NDA #206910 | SUPPL-14 | DEFERASIROX | NOVARTIS PHARMS CORP | Efficacy | Approval |
| May 24 | JADENU SPRINKLE NDA #207968 | SUPPL-8 | DEFERASIROX | NOVARTIS PHARMS CORP | Efficacy | Approval |
| May 24 | ALIQOPA NDA #209936 | SUPPL-2 | COPANLISIB DIHYDROCHLORIDE | BAYER HEALTHCARE | Labeling | Approval |
| May 24 | BRAFTOVI NDA #210496 | SUPPL-3 | ENCORAFENIB | ARRAY BIOPHARMA INC | Efficacy | Approval |
| May 24 | DAPAGLIFLOZIN ANDA #211156 | ORIG-1 | DAPAGLIFLOZIN | INVENTIA HLTHCARE | Tentative Approval | |
| May 24 | PIQRAY NDA #212526 | ORIG-1 | ALPELISIB | NOVARTIS PHARMS CORP | Type 1 - New Molecular Entity | Approval |
| May 28 | REVLIMID NDA #021880 | SUPPL-57 | LENALIDOMIDE | CELGENE | Efficacy | Approval |
| May 28 | PREZISTA NDA #021976 | SUPPL-56 | DARUNAVIR ETHANOLATE | JANSSEN PRODS | Labeling | Approval |
| May 28 | LINEZOLID ANDA #200904 | SUPPL-4 | LINEZOLID | SANDOZ INC | Labeling | Approval |
| May 28 | LINEZOLID ANDA #200904 | SUPPL-8 | LINEZOLID | SANDOZ INC | Labeling | Approval |
| May 28 | PREZISTA NDA #202895 | SUPPL-27 | DARUNAVIR ETHANOLATE | JANSSEN PRODS | Labeling | Approval |
| May 28 | CLOPIDOGREL BISULFATE ANDA #204359 | SUPPL-3 | CLOPIDOGREL BISULFATE | CSPC OUYI | Labeling | Approval |
| May 28 | CLOPIDOGREL BISULFATE ANDA #204359 | SUPPL-4 | CLOPIDOGREL BISULFATE | CSPC OUYI | Labeling | Approval |
| May 28 | CLOPIDOGREL BISULFATE ANDA #204359 | SUPPL-5 | CLOPIDOGREL BISULFATE | CSPC OUYI | Labeling | Approval |
| May 28 | CLOPIDOGREL BISULFATE ANDA #204359 | SUPPL-7 | CLOPIDOGREL BISULFATE | CSPC OUYI | Manufacturing (CMC) | Approval |
| May 28 | CLOPIDOGREL BISULFATE ANDA #204359 | SUPPL-8 | CLOPIDOGREL BISULFATE | CSPC OUYI | Labeling | Approval |
| May 28 | LOPERAMIDE HYDROCHLORIDE ANDA #206548 | SUPPL-1 | LOPERAMIDE HYDROCHLORIDE | AUROBINDO PHARMA LTD | Manufacturing (CMC) | Approval |
| May 28 | LINEZOLID ANDA #207354 | SUPPL-3 | LINEZOLID | NANG KUANG PHARM CO | Labeling | Approval |
| May 28 | LINEZOLID ANDA #207354 | SUPPL-4 | LINEZOLID | NANG KUANG PHARM CO | Labeling | Approval |
| May 28 | RANOLAZINE ANDA #208862 | ORIG-1 | RANOLAZINE | ACTAVIS ELIZABETH | Approval | |
| May 28 | MELPHALAN HYDROCHLORIDE ANDA #209826 | ORIG-1 | MELPHALAN HYDROCHLORIDE | GLAND PHARMA LTD | Approval | |
| May 28 | RANOLAZINE ANDA #210054 | ORIG-1 | RANOLAZINE | AJANTA PHARMA LTD | Approval | |
| May 28 | HEPARIN SODIUM ANDA #211007 | ORIG-1 | HEPARIN SODIUM | NANJING KING-FRIEND | Approval | |
| May 28 | RANOLAZINE ANDA #211291 | ORIG-1 | RANOLAZINE | CIPLA | Approval | |
| May 28 | RANOLAZINE ANDA #211707 | ORIG-1 | RANOLAZINE | SUN PHARM | Approval | |
| May 29 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #016677 | SUPPL-169 | SODIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| May 29 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018016 | SUPPL-67 | SODIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| May 29 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #020178 | SUPPL-21 | SODIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| May 29 | BROVANA NDA #021912 | SUPPL-32 | ARFORMOTEROL TARTRATE | SUNOVION | Labeling | Approval |
| May 29 | PERFOROMIST NDA #022007 | SUPPL-15 | FORMOTEROL FUMARATE | MYLAN SPECLT | Labeling | Approval |
| May 29 | ARCAPTA NEOHALER NDA #022383 | SUPPL-7 | INDACATEROL MALEATE | SUNOVION PHARMS INC | Labeling | Approval |
| May 29 | ROCURONIUM BROMIDE ANDA #091115 | SUPPL-11 | ROCURONIUM BROMIDE | TAMARANG | Labeling | Approval |
| May 29 | STRIVERDI RESPIMAT NDA #203108 | SUPPL-8 | OLODATEROL HYDROCHLORIDE | BOEHRINGER
INGELHEIM | Labeling | Approval |
| May 29 | ANORO ELLIPTA NDA #203975 | SUPPL-9 | UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | GLAXOSMITHKLINE | Labeling | Approval |
| May 29 | MOVANTIK NDA #204760 | SUPPL-8 | NALOXEGOL OXALATE | ASTRAZENECA PHARMS | Labeling | Approval |
| May 29 | DAPIPRAZOLE HYDROCHLORIDE ANDA #204902 | ORIG-1 | DAPIPRAZOLE HYDROCHLORIDE | BARADAINA LLC | Approval | |
| May 29 | PREZCOBIX NDA #205395 | SUPPL-14 | COBICISTAT; DARUNAVIR ETHANOLATE | JANSSEN PRODS | Labeling | Approval |
| May 29 | STIOLTO RESPIMAT NDA #206756 | SUPPL-11 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | BOEHRINGER INGELHEIM | Labeling | Approval |
| May 29 | UTIBRON NDA #207930 | SUPPL-4 | GLYCOPYRROLATE ; INDACATEROL
MALEATE | SUNOVION PHARMS INC | Labeling | Approval |
| May 29 | BEVESPI AEROSPHERE NDA #208294 | SUPPL-5 | FORMOTEROL FUMARATE; GLYCOPYRROLATE | ASTRAZENECA PHARMS | Labeling | Approval |
| May 29 | PLENVU NDA #209381 | SUPPL-2 | ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE | SALIX | Labeling | Approval |
| May 29 | XOSPATA NDA #211349 | SUPPL-1 | GILTERITINIB FUMARATE | ASTELLAS | Efficacy | Approval |
| May 29 | FULPHILA BLA #761075 | SUPPL-4 | PEGFILGRASTIM-JMDB | MYLAN GMBH | Approval | |
| May 30 | ANDROGEL NDA #021015 | SUPPL-46 | TESTOSTERONE | ABBVIE | REMS | Approval |
| May 30 | TESTIM NDA #021454 | SUPPL-29 | TESTOSTERONE | AUXILIUM PHARMS LLC | REMS | Approval |
| May 30 | FORTESTA NDA #021463 | SUPPL-21 | TESTOSTERONE | ENDO PHARMS | REMS | Approval |
| May 30 | ALLEGRA NDA #021963 | SUPPL-7 | FEXOFENADINE HYDROCHLORIDE | SANOFI AVENTIS US | Labeling | Approval |
| May 30 | ANDROGEL NDA #022309 | SUPPL-21 | TESTOSTERONE | ABBVIE | REMS | Approval |
| May 30 | MOZOBIL NDA #022311 | SUPPL-20 | PLERIXAFOR | GENZYME | Labeling | Approval |
| May 30 | MYOZYME BLA #125141 | SUPPL-222 | ALGLUCOSIDASE ALFA | GENZYME | Approval | |
| May 30 | LUMIZYME BLA #125291 | SUPPL-148 | ALGLUCOSIDASE ALFA | GENZYME | Approval | |
| May 30 | FYCOMPA NDA #202834 | SUPPL-16 | PERAMPANEL | EISAI INC | Labeling | Approval |
| May 30 | VOGELXO NDA #204399 | SUPPL-11 | TESTOSTERONE | UPSHER SMITH LABS | REMS | Approval |
| May 30 | VIGABATRIN ANDA #208218 | SUPPL-4 | VIGABATRIN | PAR PHARM INC | REMS | Approval |
| May 30 | FYCOMPA NDA #208277 | SUPPL-4 | PERAMPANEL | EISAI INC | Labeling | Approval |
| May 30 | VIGABATRIN ANDA #209822 | SUPPL-2 | VIGABATRIN | TEVA PHARMS USA | REMS | Approval |
| May 30 | VIGABATRIN ANDA #209824 | SUPPL-2 | VIGABATRIN | TEVA PHARMS USA | REMS | Approval |
| May 30 | VIGABATRIN ANDA #210155 | SUPPL-2 | VIGABATRIN | AMNEAL PHARMS | REMS | Approval |
| May 30 | VIGADRONE ANDA #210196 | SUPPL-1 | VIGABATRIN | SHANGHAI | REMS | Approval |
| May 30 | SYMTUZA NDA #210455 | SUPPL-4 | COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | JANSSEN PRODS | Labeling | Approval |
| May 30 | VIGABATRIN ANDA #211481 | SUPPL-1 | VIGABATRIN | DR REDDYS LABS LTD | REMS | Approval |
| May 31 | SABRIL NDA #020427 | SUPPL-19 | VIGABATRIN | LUNDBECK PHARMS LLC | REMS | Approval |
| May 31 | SABRIL NDA #022006 | SUPPL-21 | VIGABATRIN | LUNDBECK PHARMS LLC | REMS | Approval |
| May 31 | GLIMEPIRIDE ANDA #076802 | SUPPL-20 | GLIMEPIRIDE | TEVA | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #077091 | SUPPL-15 | GLIMEPIRIDE | DR REDDYS LABS LTD | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #077091 | SUPPL-17 | GLIMEPIRIDE | DR REDDYS LABS LTD | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #077274 | SUPPL-9 | GLIMEPIRIDE | EPIC PHARMA LLC | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #077624 | SUPPL-7 | GLIMEPIRIDE | MYLAN | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #077911 | SUPPL-4 | GLIMEPIRIDE | CARLSBAD | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #077911 | SUPPL-5 | GLIMEPIRIDE | CARLSBAD | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #078181 | SUPPL-14 | GLIMEPIRIDE | ACCORD HLTHCARE | Labeling | Approval |
| May 31 | MEMANTINE HYDROCHLORIDE ANDA #200891 | SUPPL-6 | MEMANTINE HYDROCHLORIDE | ALEMBIC PHARMS LTD | Labeling | Approval |
| May 31 | GLIMEPIRIDE ANDA #202759 | SUPPL-8 | GLIMEPIRIDE | AUROBINDO PHARMA LTD | Labeling | Approval |
| May 31 | PROCYSBI NDA #203389 | SUPPL-22 | CYSTEAMINE BITARTRATE | HORIZON PHARMA USA | Labeling | Approval |
| May 31 | TESTOSTERONE ANDA #204255 | SUPPL-5 | TESTOSTERONE | PERRIGO ISRAEL | REMS | Approval |
| May 31 | ENTECAVIR ANDA #205740 | SUPPL-2 | ENTECAVIR | HETERO LABS LTD V | Labeling | Approval |
| May 31 | ENTECAVIR ANDA #205740 | SUPPL-3 | ENTECAVIR | HETERO LABS LTD V | Labeling | Approval |
| May 31 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DETROAMP SULFATE AND AMP SULFATE ANDA #206159 | ORIG-1 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | PAR PHARM INC | Approval | |
| May 31 | BUSULFAN ANDA #209580 | SUPPL-1 | BUSULFAN | AMNEAL PHARMS CO | Labeling | Approval |
| May 31 | BUSULFAN ANDA #209580 | SUPPL-2 | BUSULFAN | AMNEAL PHARMS CO | Labeling | Approval |
| May 31 | ATOVAQUONE ANDA #210510 | ORIG-1 | ATOVAQUONE | ABHAI LLC | Approval | |
| May 31 | CARFILZOMIB ANDA #211185 | ORIG-1 | CARFILZOMIB | APOTEX INC | Tentative Approval | |
| May 31 | FELBAMATE ANDA #211333 | ORIG-1 | FELBAMATE | VISTAPHARM | Approval | |
| May 31 | SILDENAFIL CITRATE ANDA #212260 | ORIG-1 | SILDENAFIL CITRATE | NOVITIUM PHARMA | Approval |
