The U.S. Food and Drug Administration approved 438 drug products in April, 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.
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FDA Drug Approvals in April
| Approval Date | Drug Name | Submission | Company | Submission Classification | Submission Status |
| April 1 | DOCETAXEL ANDA #204193 | SUPPL-6 | DR REDDYS LABS LTD | Labeling | Approval |
| April 1 | DOCETAXEL ANDA #208137 | ORIG-1 | MYLAN LABS LTD | Approval | |
| April 1 | MIRABEGRON ANDA #209488 | ORIG-1 | ZYDUS PHARMS USA INC | Tentative Approval | |
| April 1 | PANTOPRAZOLE SODIUM ANDA #209524 | ORIG-1 | HANGZHOU ZHONGMEI HUADONG | Tentative Approval | |
| April 1 | LEVOCETIRIZINE HYDROCHLORIDE ANDA #210914 | ORIG-1 | HETERO LABS LTD III | Approval | |
| April 2 | VYTORIN NDA #021687 | SUPPL-52 | MSD INTL | Labeling | Approval |
| April 2 | XYZAL NDA #022064 | SUPPL-38 | SANOFI AVENTIS US | Labeling | Approval |
| April 2 | XYZAL NDA #022157 | SUPPL-20 | SANOFI AVENTIS US | Labeling | Approval |
| April 2 | ADDYI NDA #022526 | SUPPL-7 | SPROUT PHARMS | REMS | Approval |
| April 2 | BENAZEPRIL HYDROCHLORIDE ANDA #076430 | SUPPL-12 | MYLAN | Labeling | Approval |
| April 2 | BENAZEPRIL HYDROCHLORIDE ANDA #077128 | SUPPL-15 | APOTEX INC | Labeling | Approval |
| April 2 | BENAZEPRIL HYDROCHLORIDE ANDA #078212 | SUPPL-17 | AUROBINDO PHARMA | Labeling | Approval |
| April 2 | EPLERENONE ANDA #078510 | SUPPL-13 | SANDOZ | Labeling | Approval |
| April 2 | EPLERENONE ANDA #078510 | SUPPL-14 | SANDOZ | Labeling | Approval |
| April 2 | CELECOXIB ANDA #078857 | SUPPL-5 | MYLAN | Labeling | Approval |
| April 2 | AZELASTINE HYDROCHLORIDE ANDA #090423 | SUPPL-19 | SUN PHARM | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #091479 | SUPPL-10 | TORRENT PHARMS LTD | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #091479 | SUPPL-11 | TORRENT PHARMS LTD | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #201150 | SUPPL-3 | MYLAN PHARMS INC | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #201150 | SUPPL-6 | MYLAN PHARMS INC | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #201150 | SUPPL-7 | MYLAN PHARMS INC | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #201150 | SUPPL-9 | MYLAN PHARMS INC | Labeling | Approval |
| April 2 | LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #201653 | SUPPL-4 | SUN PHARM INDS LTD | Labeling | Approval |
| April 2 | LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #201653 | SUPPL-5 | SUN PHARM INDS LTD | Labeling | Approval |
| April 2 | LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #201653 | SUPPL-6 | SUN PHARM INDS LTD | Labeling | Approval |
| April 2 | EZETIMIBE AND SIMVASTATIN ANDA #201890 | SUPPL-5 | ANI PHARMS INC | Labeling | Approval |
| April 2 | CARISOPRODOL ANDA #203374 | SUPPL-12 | SCIEGEN PHARMS INC | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #203623 | SUPPL-1 | HETERO LABS LTD V | Labeling | Approval |
| April 2 | SILDENAFIL CITRATE ANDA #203623 | SUPPL-3 | HETERO LABS LTD V | Labeling | Approval |
| April 2 | LINEZOLID ANDA #204239 | SUPPL-1 | HETERO LABS LTD V | Labeling | Approval |
| April 2 | LINEZOLID ANDA #204239 | SUPPL-2 | HETERO LABS LTD V | Labeling | Approval |
| April 2 | TELMISARTAN ANDA #206511 | SUPPL-3 | AUROBINDO
PHARMA LTD | Labeling | Approval |
| April 2 | SELEGILINE HYDROCHLORIDE ANDA #206803 | ORIG-1 | PACK PHARMS LLC | Approval | |
| April 2 | FINGOLIMOD ANDA #207939 | ORIG-1 | HEC PHARM | Tentative Approval | |
| April 2 | ASPIRIN AND DIPYRIDAMOLE ANDA #208572 | SUPPL-1 | SUN PHARM | Labeling | Approval |
| April 2 | CELECOXIB ANDA #208833 | SUPPL-1 | AMNEAL PHARMS | Labeling | Approval |
| April 2 | BUPIVACAINE HYDROCHLORIDE ANDA #209087 | ORIG-1 | B BRAUN MEDICAL INC | Approval | |
| April 2 | CARMUSTINE ANDA #209278 | ORIG-1 | STI PHARMA LLC | Approval | |
| April 2 | BETAMETHASONE DIPROPIONATE ANDA #211540 | ORIG-1 | PERRIGO UK FINCO | Tentative Approval | |
| April 3 | LOTRONEX NDA #021107 | SUPPL-29 | SEBELA IRELAND LTD | Labeling | Approval |
| April 3 | LOVAZA NDA #021654 | SUPPL-43 | SMITHKLINE BEECHAM | Labeling | Approval |
| April 3 | BRILINTA NDA #022433 | SUPPL-23 | ASTRAZENECA PHARMS | Efficacy | Approval |
| April 3 | CLOPIDOGREL BISULFATE ANDA #090540 | SUPPL-12 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 3 | CLOPIDOGREL BISULFATE ANDA #090540 | SUPPL-13 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 3 | CLOPIDOGREL BISULFATE ANDA #090540 | SUPPL-14 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 3 | CLOPIDOGREL BISULFATE ANDA #090540 | SUPPL-15 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 3 | CLOPIDOGREL BISULFATE ANDA #090540 | SUPPL-17 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 3 | AMPICILLIN SODIUM ANDA #090889 | SUPPL-1 | ACS DOBFAR SPA | Labeling | Approval |
| April 3 | AMPICILLIN SODIUM ANDA #090889 | SUPPL-2 | ACS DOBFAR SPA | Labeling | Approval |
| April 3 | AVASTIN BLA #125085 | SUPPL-329 | GENENTECH | Approval | |
| April 3 | EPLERENONE ANDA #206922 | SUPPL-1 | ACCORD HLTHCARE | Labeling | Approval |
| April 3 | ROSUVASTATIN CALCIUM ANDA #207408 | SUPPL-2 | CHANGZHOU PHARM | Labeling | Approval |
| April 3 | ROSUVASTATIN CALCIUM ANDA #207408 | SUPPL-8 | CHANGZHOU PHARM | Labeling | Approval |
| April 3 | ESTRADIOL AND NORETHINDRONE ACETATE ANDA #210612 | ORIG-1 | NOVAST LABS | Approval | |
| April 3 | WELCHOL NDA #210895 | ORIG-1 | DAIICHI SANKYO
INC | Type 3 - New Dosage Form | Approval |
| April 3 | PERMETHRIN ANDA #211303 | ORIG-1 | ENCUBE ETHICALS | Approval | |
| April 3 | FLUOCINONIDE ANDA #211758 | ORIG-1 | TELIGENT PHARMA INC | Approval | |
| April 4 | SOMA NDA #011792 | SUPPL-50 | MYLAN SPECIALITY LP | Labeling | Approval |
| April 4 | ZANTAC 75 NDA #020520 | SUPPL-37 | SANOFI US | Labeling | Approval |
| April 4 | PRILOSEC OTC NDA #021229 | SUPPL-33 | ASTRAZENECA PHARMS | Labeling | Approval |
| April 4 | ZANTAC 150 NDA #021698 | SUPPL-29 | SANOFI US | Labeling | Approval |
| April 4 | MOMETASONE FUROATE ANDA #075919 | SUPPL-6 | FOUGERA PHARMS | Labeling | Approval |
| April 4 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #091629 | SUPPL-19 | AUROBINDO PHARMA | Manufacturing (CMC) | Approval |
| April 4 | BICALUTAMIDE ANDA #200274 | SUPPL-1 | APOTEX INC | Labeling | Approval |
| April 4 | BICALUTAMIDE ANDA #200274 | SUPPL-2 | APOTEX INC | Labeling | Approval |
| April 4 | BUSULFAN ANDA #202259 | SUPPL-2 | LUITPOLD | Labeling | Approval |
| April 4 | BUSULFAN ANDA #202259 | SUPPL-4 | LUITPOLD | Labeling | Approval |
| April 4 | BUSULFAN ANDA #202259 | SUPPL-6 | LUITPOLD | Labeling | Approval |
| April 4 | TELMISARTAN AND AMLODIPINE ANDA #202517 | SUPPL-4 | TORRENT | Labeling | Approval |
| April 4 | TELMISARTAN AND AMLODIPINE ANDA #202517 | SUPPL-7 | TORRENT | Labeling | Approval |
| April 4 | LOSARTAN POTASSIUM ANDA #203835 | SUPPL-4 | HETERO LABS LTD V | Labeling | Approval |
| April 4 | RIVASTIGMINE TARTRATE ANDA #204572 | SUPPL-2 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 4 | RIVASTIGMINE TARTRATE ANDA #204572 | SUPPL-5 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 4 | NEXIUM 24HR NDA #204655 | SUPPL-11 | ASTRAZENECA LP | Labeling | Approval |
| April 4 | LOSARTAN POTASSIUM ANDA #204795 | ORIG-1 | HISUN PHARM HANGZHOU | Approval | |
| April 4 | BUSULFAN ANDA #205106 | SUPPL-1 | ATHENEX INC | Labeling | Approval |
| April 4 | BUSULFAN ANDA #205139 | SUPPL-2 | ACTAVIS LLC | Labeling | Approval |
| April 4 | BUSULFAN ANDA #205139 | SUPPL-3 | ACTAVIS LLC | Labeling | Approval |
| April 4 | TIGECYCLINE NDA #205645 | SUPPL-3 | FRESENIUS KABI USA | Labeling | Approval |
| April 4 | PITAVASTATIN CALCIUM ANDA #206070 | ORIG-1 | MYLAN PHARMS INC | Approval | |
| April 4 | ENTECAVIR ANDA #206745 | SUPPL-1 | ZYDUS PHARMS | Labeling | Approval |
| April 4 | ENTECAVIR ANDA #206745 | SUPPL-3 | ZYDUS PHARMS | Labeling | Approval |
| April 4 | ENTECAVIR ANDA #206745 | SUPPL-4 | ZYDUS PHARMS | Labeling | Approval |
| April 4 | IBRANCE NDA #207103 | SUPPL-8 | PFIZER INC | Efficacy | Approval |
| April 4 | NEXIUM 24HR NDA #207920 | SUPPL-5 | ASTRAZENECA LP | Labeling | Approval |
| April 4 | HALOPERIDOL DECANOATE ANDA #209101 | SUPPL-1 | SOMERSET THERAPS LLC | Labeling | Approval |
| April 4 | HALOPERIDOL DECANOATE ANDA #209101 | SUPPL-2 | SOMERSET THERAPS LLC | Labeling | Approval |
| April 4 | PLENVU NDA #209381 | SUPPL-1 | SALIX | Labeling | Approval |
| April 4 | OLOPATADINE HYDROCHLORIDE ANDA #209995 | ORIG-1 | AUROBINDO PHARMA LTD | Approval | |
| April 4 | TREMFYA BLA #761061 | SUPPL-2 | JANSSEN BIOTECH | Approval | |
| April 5 | RAPAMUNE NDA #021083 | SUPPL-65 | PF PRISM CV | Labeling | Approval |
| April 5 | RAPAMUNE NDA #021110 | SUPPL-84 | PF PRISM CV | Labeling | Approval |
| April 5 | SERTRALINE HYDROCHLORIDE ANDA #076934 | SUPPL-7 | ACI HEALTHCARE LTD | Labeling | Approval |
| April 5 | METOCLOPRAMIDE HYDROCHLORIDE ANDA #078807 | SUPPL-10 | IPCA LABS LTD | Labeling | Approval |
| April 5 | ARIPIPRAZOLE ANDA #201519 | SUPPL-33 | TORRENT | Labeling | Approval |
| April 5 | ARIPIPRAZOLE ANDA #201519 | SUPPL-35 | TORRENT | Labeling | Approval |
| April 5 | ARIPIPRAZOLE ANDA #201519 | SUPPL-36 | TORRENT | Labeling | Approval |
| April 5 | DIFICID NDA #201699 | SUPPL-11 | CUBIST PHARMS LLC | Labeling | Approval |
| April 5 | KETOROLAC TROMETHAMINE ANDA #203410 | ORIG-1 | MICRO LABS LTD INDIA | Approval | |
| April 5 | LACOSAMIDE ANDA #204947 | ORIG-1 | ZYDUS PHARMS USA INC | Tentative Approval | |
| April 5 | TOFACITINIB CITRATE ANDA #209829 | ORIG-1 | ZYDUS PHARMS USA INC | Tentative Approval | |
| April 5 | Bortezomib ANDA #210615 | ORIG-1 | SHILPA MEDICARE LTD | Tentative Approval | |
| April 5 | THIOTHIXENE ANDA #211642 | ORIG-1 | NOVITIUM PHARMA | Approval | |
| April 5 | RANITIDINE HYDROCHLORIDE ANDA #211893 | ORIG-1 | APPCO PHARMA LLC | Approval | |
| April 8 | ULTRAM NDA #020281 | SUPPL-41 | JANSSEN PHARMS | Labeling | Approval |
| April 8 | SOLTAMOX NDA #021807 | SUPPL-6 | MIDATECH PHARMA US | Labeling | Approval |
| April 8 | OMEPRAZOLE NDA #022032 | SUPPL-41 | DEXCEL PHARMA | Labeling | Approval |
| April 8 | IMATINIB MESYLATE ANDA #078340 | SUPPL-5 | SUN PHARM | Labeling | Approval |
| April 8 | IMATINIB MESYLATE ANDA #078340 | SUPPL-6 | SUN PHARM | Labeling | Approval |
| April 8 | IMATINIB MESYLATE ANDA #078340 | SUPPL-7 | SUN PHARM | Labeling | Approval |
| April 8 | IMATINIB MESYLATE ANDA #078340 | SUPPL-8 | SUN PHARM | Labeling | Approval |
| April 8 | IMATINIB MESYLATE ANDA #078340 | SUPPL-9 | SUN PHARM | Labeling | Approval |
| April 8 | IMATINIB MESYLATE ANDA #078340 | SUPPL-12 | SUN PHARM | Labeling | Approval |
| April 8 | MENEST ANDA #084948 | SUPPL-23 | MONARCH PHARMS | Labeling | Approval |
| April 8 | MENEST ANDA #084949 | SUPPL-23 | MONARCH PHARMS | Labeling | Approval |
| April 8 | MENEST ANDA #084950 | SUPPL-20 | MONARCH PHARMS | Labeling | Approval |
| April 8 | MENEST ANDA #084951 | SUPPL-24 | MONARCH PHARMS | Labeling | Approval |
| April 8 | TETRABENAZINE ANDA #209739 | ORIG-1 | WEST-WARD PHARMS INT | Approval | |
| April 8 | ICATIBANT ANDA #210118 | ORIG-1 | TEVA PHARMS USA INC | Tentative Approval | |
| April 8 | CLOMIPRAMINE HYDROCHLORIDE ANDA #211767 | ORIG-1 | MANKIND PHARMA | Approval | |
| April 8 | DOLUTEGRAVIR; LAMIVUDINE NDA #211994 | ORIG-1 | VIIV HLTHCARE | Type 4 - New Combination | Approval |
| April 9 | PAMELOR NDA #018013 | SUPPL-64 | SPECGX LLC | Labeling | Approval |
| April 9 | PEPCID AC NDA #020325 | SUPPL-33 | J AND J CONSUMER INC | Labeling | Approval |
| April 9 | AXID AR NDA #020555 | SUPPL-10 | PFIZER | Labeling | Approval |
| April 9 | VAGIFEM NDA #020908 | SUPPL-26 | NOVO NORDISK INC | Labeling | Approval |
| April 9 | PEPCID COMPLETE NDA #020958 | SUPPL-28 | J AND J CONSUMER INC | Labeling | Approval |
| April 9 | PREVACID 24 HR NDA #022327 | SUPPL-27 | GLAXOSMITHKLINE CONS | Labeling | Approval |
| April 9 | ROSUVASTATIN CALCIUM ANDA #207626 | ORIG-1 | UMEDICA LABS PVT LTD | Approval | |
| April 9 | LANSOPRAZOLE NDA #208025 | SUPPL-8 | DEXCEL PHARMA | Labeling | Approval |
| April 9 | HYDROXYPROGESTERONE CAPROATE ANDA #208381 | ORIG-1 | SUN PHARM | Approval | |
| April 9 | DECITABINE ANDA #209056 | ORIG-1 | WOCKHARDT BIO AG | Approval | |
| April 9 | SEYSARA NDA #209521 | SUPPL-1 | ALMIRALL | Labeling | Approval |
| April 9 | OZEMPIC NDA #209637 | SUPPL-1 | NOVO | Labeling | Approval |
| April 9 | EVENITY BLA #761062 | ORIG-1 | AMGEN INC | Approval | |
| April 10 | WELCHOL NDA #022362 | SUPPL-24 | DAIICHI SANKYO | Labeling | Approval |
| April 10 | TESTOSTERONE ANDA #204570 | ORIG-1 | ACTAVIS LABS UT INC | Approval | |
| April 10 | ALEVE PM NDA #205352 | SUPPL-13 | BAYER HLTHCARE | Labeling | Approval |
| April 10 | TESTOSTERONE ANDA #207373 | ORIG-1 | AMNEAL PHARMS LLC | Approval | |
| April 10 | LURASIDONE HYDROCHLORIDE ANDA #208058 | ORIG-1 | EMCURE PHARMS LTD | Tentative Approval | |
| April 10 | NAFTIFINE HYDROCHLORIDE ANDA #208201 | ORIG-1 | TARO | Approval | |
| April 10 | AMBRISENTAN ANDA #208354 | ORIG-1 | SIGMAPHARM LABS LLC | Approval | |
| April 10 | TESTOSTERONE ANDA #208560 | ORIG-1 | LUPIN ATLANTIS | Approval | |
| April 10 | TESTOSTERONE ANDA #208620 | ORIG-1 | DR REDDYS LABS INC | Approval | |
| April 10 | AMBRISENTAN ANDA #209509 | ORIG-1 | PAR PHARM INC | Approval | |
| April 10 | ESOMEPRAZOLE MAGNESIUM ANDA #209647 | ORIG-1 | AMNEAL PHARMS NY | Approval | |
| April 10 | SODIUM NITROPRUSSIDE ANDA #210114 | ORIG-1 | DR REDDYS LABS LTD | Approval | |
| April 10 | TEMIXYS NDA #211284 | SUPPL-1 | CELLTRION | Labeling | Approval |
| April 11 | DESOXYN NDA #005378 | SUPPL-35 | RECORDATI RARE | Labeling | Approval |
| April 11 | SANDOSTATIN NDA #019667 | SUPPL-67 | NOVARTIS | Labeling | Approval |
| April 11 | NAPHCON-A NDA #020226 | SUPPL-29 | ALCON | Labeling | Approval |
| April 11 | MIFEPREX NDA #020687 | SUPPL-22 | DANCO LABS LLC | REMS | Approval |
| April 11 | SANDOSTATIN LAR NDA #021008 | SUPPL-43 | NOVARTIS | Labeling | Approval |
| April 11 | SOMATULINE DEPOT NDA #022074 | SUPPL-24 | IPSEN PHARMA | Labeling | Approval |
| April 11 | ZYPREXA RELPREVV NDA #022173 | SUPPL-32 | ELI LILLY CO | REMS | Approval |
| April 11 | ADDYI NDA #022526 | SUPPL-6 | SPROUT PHARMS | Supplement | Approval |
| April 11 | CLOPIDOGREL BISULFATE ANDA #077665 | SUPPL-7 | MYLAN PHARMS INC | Labeling | Approval |
| April 11 | MIFEPRISTONE ANDA #091178 | ORIG-1 | GENBIOPRO | Approval | |
| April 11 | ACTEMRA BLA #125276 | SUPPL-120 | GENENTECH | Approval | |
| April 11 | ACTEMRA BLA #125276 | SUPPL-121 | GENENTECH | Approval | |
| April 11 | ACTEMRA BLA #125472 | SUPPL-37 | GENENTECH | Approval | |
| April 11 | KEYTRUDA BLA #125514 | SUPPL-47 | MERCK SHARP DOHME | Approval | |
| April 11 | REPATHA BLA #125522 | SUPPL-20 | AMGEN INC | Approval | |
| April 11 | SIGNIFOR NDA #200677 | SUPPL-5 | NOVARTIS | Labeling | Approval |
| April 11 | SIGNIFOR LAR KIT NDA #203255 | SUPPL-7 | NOVARTIS PHARMS CORP | Labeling | Approval |
| April 11 | EPLERENONE ANDA #203896 | SUPPL-2 | MYLAN | Labeling | Approval |
| April 11 | LEVOTHYROXINE SODIUM NDA #210632 | ORIG-1 | FRESENIUS KABI USA | Type 3 - New Dosage Form | Approval |
| April 12 | BECONASE AQ NDA #019389 | SUPPL-34 | GLAXOSMITHKLINE | Labeling | Approval |
| April 12 | LIPITOR NDA #020702 | SUPPL-73 | PFIZER | Labeling | Approval |
| April 12 | CYPROHEPTADINE HYDROCHLORIDE ANDA #206676 | ORIG-1 | BEXIMCO PHARMS USA | Approval | |
| April 12 | DAUNORUBICIN HYDROCHLORIDE ANDA #208759 | ORIG-1 | HISUN PHARM HANGZHOU | Approval | |
| April 12 | BIMATOPROST ANDA #210263 | ORIG-1 | ALEMBIC PHARMS LTD | Approval | |
| April 12 | BALVERSA NDA #212018 | ORIG-1 | JANSSEN BIOTECH | Type 1 - New Molecular Entity | Approval |
| April 15 | EXCEDRIN (MIGRAINE) NDA #020802 | SUPPL-33 | GLAXOSMITHKLINE CONS | Labeling | Approval |
| April 15 | VERDESO NDA #021978 | SUPPL-15 | ALMIRALL | Labeling | Approval |
| April 15 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375 | SUPPL-9 | HIKMA FARMACEUTICA | Labeling | Approval |
| April 15 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375 | SUPPL-12 | HIKMA FARMACEUTICA | Labeling | Approval |
| April 15 | ACETAZOLAMIDE SODIUM ANDA #206533 | ORIG-1 | ZYDUS PHARMS | Approval | |
| April 15 | DOXYCYCLINE HYCLATE ANDA #209243 | ORIG-1 | APOTEX INC | Approval | |
| April 15 | CLOBAZAM ANDA #210978 | ORIG-1 | TARO PHARM | Approval | |
| April 15 | FLUOXETINE HYDROCHLORIDE ANDA #211653 | ORIG-1 | LUPIN LTD | Approval | |
| April 15 | TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION NDA #212020 | ORIG-1 | EXELA PHARMA SCIENCE | Type 5 - New Formulation or New Manufacturer | Approval |
| April 16 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020488 | SUPPL-24 | HOSPIRA | Labeling | Approval |
| April 16 | CIPROFLOXACIN ANDA #076717 | SUPPL-6 | HIKMA FARMACEUTICA | Labeling | Approval |
| April 16 | RIVASTIGMINE TARTRATE ANDA #077131 | SUPPL-6 | SUN PHARM | Labeling | Approval |
| April 16 | RIVASTIGMINE TARTRATE ANDA #077131 | SUPPL-10 | SUN PHARM | Labeling | Approval |
| April 16 | LEVOFLOXACIN ANDA #077652 | SUPPL-8 | ZYDUS PHARMS USA INC | Labeling | Approval |
| April 16 | LEVOFLOXACIN ANDA #077652 | SUPPL-10 | ZYDUS PHARMS USA INC | Labeling | Approval |
| April 16 | LEVOFLOXACIN ANDA #077652 | SUPPL-14 | ZYDUS PHARMS USA INC | Labeling | Approval |
| April 16 | LEVOFLOXACIN ANDA #077652 | SUPPL-15 | ZYDUS PHARMS USA INC | Labeling | Approval |
| April 16 | SUMATRIPTAN SUCCINATE ANDA #077744 | SUPPL-8 | MYLAN | Labeling | Approval |
| April 16 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252 | SUPPL-30 | INFORLIFE | Labeling | Approval |
| April 16 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252 | SUPPL-31 | INFORLIFE | Labeling | Approval |
| April 16 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078431 | SUPPL-9 | HIKMA FARMACEUTICA | Labeling | Approval |
| April 16 | ROCURONIUM BROMIDE ANDA #078717 | SUPPL-23 | TEVA PHARMS | Labeling | Approval |
| April 16 | BICALUTAMIDE ANDA #079089 | SUPPL-4 | ZYDUS PHARMS USA INC | Labeling | Approval |
| April 16 | BICALUTAMIDE ANDA #079089 | SUPPL-5 | ZYDUS PHARMS USA INC | Labeling | Approval |
| April 16 | ROCURONIUM BROMIDE ANDA #079199 | SUPPL-9 | MYLAN INSTITUTIONAL | Labeling | Approval |
| April 16 | ROCURONIUM BROMIDE ANDA #079199 | SUPPL-10 | MYLAN INSTITUTIONAL | Labeling | Approval |
| April 16 | NEULASTA BLA #125031 | SUPPL-198 | AMGEN | Approval | |
| April 16 | BUSPIRONE HYDROCHLORIDE ANDA #202087 | SUPPL-1 | YILING PHARM LTD | Labeling | Approval |
| April 16 | TELMISARTAN ANDA #202130 | SUPPL-8 | ALEMBIC PHARMS LTD | Labeling | Approval |
| April 16 | TELMISARTAN ANDA #203325 | SUPPL-3 | ZYDUS PHARMS | Labeling | Approval |
| April 16 | LEVOFLOXACIN ANDA #203613 | SUPPL-2 | JUBILANT GENERICS | Labeling | Approval |
| April 16 | LEVOFLOXACIN ANDA #203613 | SUPPL-3 | JUBILANT GENERICS | Labeling | Approval |
| April 16 | ROCURONIUM BROMIDE ANDA #204679 | SUPPL-4 | WEST WARD PHARM CORP | Labeling | Approval |
| April 16 | DESIPRAMINE HYDROCHLORIDE ANDA #205153 | SUPPL-1 | ANI PHARMS INC | Labeling | Approval |
| April 16 | RIVASTIGMINE ANDA #205622 | SUPPL-1 | MYLAN TECHNOLOGIES | Labeling | Approval |
| April 16 | ENTECAVIR ANDA #206652 | SUPPL-2 | AMNEAL PHARMS | Labeling | Approval |
| April 16 | ENTECAVIR ANDA #206652 | SUPPL-3 | AMNEAL PHARMS | Labeling | Approval |
| April 16 | ENTECAVIR ANDA #206652 | SUPPL-5 | AMNEAL PHARMS | Labeling | Approval |
| April 16 | ASPIRIN AND DIPYRIDAMOLE ANDA #206964 | SUPPL-7 | ANI PHARMS INC | Labeling | Approval |
| April 16 | DESIPRAMINE HYDROCHLORIDE ANDA #207433 | SUPPL-3 | HERITAGE PHARMS INC | Labeling | Approval |
| April 16 | DESIPRAMINE HYDROCHLORIDE ANDA #208105 | SUPPL-4 | AMNEAL PHARMS CO | Labeling | Approval |
| April 16 | BUSPIRONE HYDROCHLORIDE ANDA #208972 | ORIG-1 | EPIC PHARMA LLC | Approval | |
| April 16 | EZETIMIBE AND SIMVASTATIN ANDA
#209222 | SUPPL-2 | ALKEM LABS LTD | Labeling | Approval |
| April 16 | ELCYS NDA #210660 | ORIG-1 | EXELA PHARMA SCS LLC | Type 5 - New Formulation or New Manufacturer | Approval |
| April 16 | NIFEDIPINE ANDA #210838 | ORIG-1 | SPIL | Approval | |
| April 16 | HYDROXYPROGESTERONE CAPROATE ANDA #211070 | ORIG-1 | EUGIA PHARMA | Approval | |
| April 16 | HYDROXYPROGESTERONE CAPROATE ANDA #211071 | ORIG-1 | EUGIA PHARMA | Approval | |
| April 16 | ACETAMINOPHEN ANDA #211544 | ORIG-1 | GRANULES INDIA LTD | Approval | |
| April 16 | UDENYCA BLA #761039 | SUPPL-1 | COHERUS BIOSCIENCES INC | Approval | |
| April 17 | LEVOFLOXACIN ANDA #078424 | SUPPL-13 | LUPIN | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #078424 | SUPPL-14 | LUPIN | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #078424 | SUPPL-16 | LUPIN | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #078424 | SUPPL-17 | LUPIN | Labeling | Approval |
| April 17 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343 | SUPPL-22 | INFORLIFE | Labeling | Approval |
| April 17 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343 | SUPPL-24 | INFORLIFE | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #090722 | SUPPL-10 | TORRENT PHARMS | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #090722 | SUPPL-11 | TORRENT PHARMS | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #090722 | SUPPL-12 | TORRENT PHARMS | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #090722 | SUPPL-13 | TORRENT PHARMS | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #200560 | SUPPL-11 | MYLAN ASI | Labeling | Approval |
| April 17 | LEVOFLOXACIN ANDA #202590 | SUPPL-6 | EMCURE PHARMS LTD | Labeling | Approval |
| April 17 | MINOCYCLINE HYDROCHLORIDE ANDA #203443 | ORIG-2 | MYLAN | Tentative Approval | |
| April 17 | METFORMIN HYDROCHLORIDE ANDA #206955 | SUPPL-12 | MACLEODS
PHARMS LTD | Manufacturing (CMC) | Approval |
| April 17 | LOTEPREDNOL ETABONATE ANDA #207609 | ORIG-1 | HI TECH | Approval | |
| April 17 | FLUTICASONE PROPIONATE ANDA #208024 | ORIG-1 | HI TECH | Approval | |
| April 17 | AZITHROMYCIN ANDA #208250 | ORIG-1 | CSPC OUYI | Approval | |
| April 17 | DULOXETINE HYDROCHLORIDE ANDA #210599 | ORIG-1 | QINGDAO BAHEAL PHARM | Approval | |
| April 17 | AMPHETAMINE SULFATE ANDA #211639 | ORIG-1 | AUROLIFE PHARMA LLC | Approval | |
| April 17 | OGIVRI BLA #761074 | SUPPL-4 | MYLAN GMBH | Approval | |
| April 18 | CIPROFLOXACIN IN DEXTROSE 5% ANDA #076757 | SUPPL-8 | HIKMA FARMACEUTICA | Labeling | Approval |
| April 18 | OPDIVO BLA #125554 | SUPPL-70 | BRISTOL MYERS SQUIBB | Approval | |
| April 18 | BLINCYTO BLA #125557 | SUPPL-15 | AMGEN | Approval | |
| April 18 | BLINCYTO BLA #125557 | SUPPL-16 | AMGEN | Approval | |
| April 18 | DONEPEZIL HYDROCHLORIDE ANDA #203114 | SUPPL-1 | OSMOTICA PHARM US | Labeling | Approval |
| April 18 | FINGOLIMOD ANDA #207945 | ORIG-1 | EZRA VENTURES LLC | Tentative Approval | |
| April 18 | NERLYNX NDA #208051 | SUPPL-3 | PUMA BIOTECH | Labeling | Approval |
| April 18 | BUSULFAN ANDA #210931 | ORIG-1 | SHILPA MEDICARE LTD | Approval | |
| April 18 | BUDESONIDE NDA #211929 | ORIG-1 | SUN PHARMA GLOBAL | Type 5 - New Formulation or New Manufacturer | Tentative Approval |
| April 19 | CLEOCIN NDA #050537 | SUPPL-40 | PHARMACIA AND UPJOHN | Labeling | Approval |
| April 19 | CLEOCIN T NDA #050537 | SUPPL-40 | PHARMACIA AND UPJOHN | Labeling | Approval |
| April 19 | CLEOCIN T NDA #050600 | SUPPL-17 | PHARMACIA AND UPJOHN | Labeling | Approval |
| April 19 | CLEOCIN T NDA #050615 | SUPPL-18 | PHARMACIA AND UPJOHN | Labeling | Approval |
| April 19 | KEYTRUDA BLA #125514 | SUPPL-54 | MERCK SHARP DOHME | Approval | |
| April 19 | VALRUBICIN ANDA #206430 | ORIG-1 | CUSTOPHARM INC | Approval | |
| April 19 | NATEGLINIDE ANDA #206432 | ORIG-1 | CADILA PHARMS LTD | Approval | |
| April 19 | MESALAMINE ANDA #207448 | ORIG-1 | PHARM SOURCING | Approval | |
| April 19 | FENOFIBRATE (MICRONIZED) ANDA #207564 | ORIG-1 | INGENUS PHARMS LLC | Approval | |
| April 19 | FINGOLIMOD ANDA #207991 | ORIG-1 | ACCORD HLTHCARE INC | Tentative Approval | |
| April 19 | AMOXICILLIN AND CLAVULANATE POTASSIUM ANDA #209371 | ORIG-1 | AUROBINDO PHARMA LTD | Approval | |
| April 19 | NALOXONE HYDROCHLORIDE ANDA #209522 | ORIG-1 | TEVA PHARMS USA | Approval | |
| April 19 | TERIFLUNOMIDE ANDA #209572 | ORIG-1 | ALEMBIC PHARMS LTD | Approval | |
| April 19 | ZOLEDRONIC ACID ANDA #209578 | ORIG-1 | GLAND PHARMA LTD | Tentative Approval | |
| April 19 | EVEROLIMUS ANDA #210130 | ORIG-1 | MYLAN PHARMS INC | Approval | |
| April 19 | HALOBETASOL PROPIONATE NDA #210566 | SUPPL-1 | MAYNE PHARMA | Labeling | Approval |
| April 19 | TOBRAMYCIN ANDA #211847 | ORIG-1 | ALEMBIC PHARMS LTD | Approval | |
| April 22 | IMPLANON NDA #021529 | SUPPL-18 | ORGANON USA INC | Labeling | Approval |
| April 22 | NEXPLANON NDA #021529 | SUPPL-18 | ORGANON USA INC | Labeling | Approval |
| April 22 | MINOXIDIL (FOR MEN) ANDA #209074 | ORIG-2 | TARO PHARM | Approval | |
| April 22 | MINOXIDIL (FOR WOMEN) ANDA #209074 | ORIG-2 | TARO PHARM | Approval | |
| April 22 | CORLANOR NDA #209964 | ORIG-1 | AMGEN INC | Type 3 - New Dosage Form | Approval |
| April 22 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #211547 | ORIG-1 | SPECGX LLC | Approval | |
| April 23 | ALLOPURINOL ANDA #018659 | SUPPL-24 | MYLAN | Labeling | Approval |
| April 23 | THYRO-TABS NDA #021116 | SUPPL-17 | ALVOGEN | Labeling | Approval |
| April 23 | AMRIX NDA #021777 | SUPPL-17 | TEVA PHARMS INTL | Labeling | Approval |
| April 23 | AZATHIOPRINE ANDA #074069 | SUPPL-14 | AMNEAL PHARMS LLC | Labeling | Approval |
| April 23 | AZATHIOPRINE ANDA #075568 | SUPPL-27 | MYLAN | Labeling | Approval |
| April 23 | AZATHIOPRINE ANDA #077621 | SUPPL-13 | ZYDUS PHARMS USA | Labeling | Approval |
| April 23 | ALLOPURINOL ANDA #078253 | SUPPL-12 | NORTHSTAR HLTHCARE | Labeling | Approval |
| April 23 | TELMISARTAN ANDA #078710 | SUPPL-4 | CIPLA | Labeling | Approval |
| April 23 | CAMPATH BLA #103948 | SUPPL-5168 | GENZYME | Approval | |
| April 23 | LEMTRADA BLA #103948 | SUPPL-5168 | GENZYME | Approval | |
| April 23 | ERBITUX BLA #125084 | SUPPL-273 | IMCLONE | Approval | |
| April 23 | METHSCOPOLAMINE BROMIDE ANDA #200602 | SUPPL-5 | BAYSHORE PHARMS LLC | Manufacturing (CMC) | Approval |
| April 23 | TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #201192 | SUPPL-6 | TORRENT | Labeling | Approval |
| April 23 | IRBESARTAN ANDA #201531 | SUPPL-6 | LUPIN LTD | Labeling | Approval |
| April 23 | DONEPEZIL HYDROCHLORIDE ANDA #202782 | SUPPL-3 | LUPIN LTD | Labeling | Approval |
| April 23 | SILDENAFIL CITRATE ANDA #203814 | SUPPL-5 | MACLEODS
PHARMS LTD | Labeling | Approval |
| April 23 | SILDENAFIL CITRATE ANDA #203814 | SUPPL-9 | MACLEODS
PHARMS LTD | Labeling | Approval |
| April 23 | SILDENAFIL CITRATE ANDA #203814 | SUPPL-12 | MACLEODS
PHARMS LTD | Labeling | Approval |
| April 23 | OPSUMIT NDA #204410 | SUPPL-17 | ACTELION PHARMS LTD | Labeling | Approval |
| April 23 | GLIPIZIDE ANDA #204720 | SUPPL-4 | UNIQUE PHARM LABS | Labeling | Approval |
| April 23 | IRBESARTAN ANDA #204740 | SUPPL-1 | AMNEAL PHARMS | Labeling | Approval |
| April 23 | ENTECAVIR ANDA #205824 | SUPPL-2 | ACCORD HLTHCARE | Labeling | Approval |
| April 23 | ENTECAVIR ANDA #205824 | SUPPL-3 | ACCORD HLTHCARE | Labeling | Approval |
| April 23 | RUFINAMIDE ANDA #207363 | ORIG-1 | HIKMA | Approval | |
| April 23 | NYSTATIN ANDA #209114 | SUPPL-1 | ACP NIMBLE | Manufacturing (CMC) | Approval |
| April 23 | ALLOPURINOL ANDA #210117 | SUPPL-1 | ZYDUS PHARMS | Labeling | Approval |
| April 23 | RUFINAMIDE ANDA #211388 | ORIG-1 | BIONPHARMA INC | Approval | |
| April 23 | SKYRIZI BLA #761105 | ORIG-1 | ABBVIE INC | Approval | |
| April 24 | VIREAD NDA #021356 | SUPPL-58 | GILEAD SCIENCES INC | Labeling | Approval |
| April 24 | VIREAD NDA #022577 | SUPPL-14 | GILEAD SCIENCES INC | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050670 | SUPPL-34 | PFIZER | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050693 | SUPPL-31 | PFIZER | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050710 | SUPPL-49 | PFIZER | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050711 | SUPPL-47 | PFIZER | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050730 | SUPPL-41 | PFIZER | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050733 | SUPPL-47 | PFIZER | Labeling | Approval |
| April 24 | ZITHROMAX NDA #050784 | SUPPL-34 | PFIZER | Labeling | Approval |
| April 24 | ZMAX NDA #050797 | SUPPL-25 | PF PRISM CV | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076710 | SUPPL-9 | DR REDDYS LABS INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076710 | SUPPL-10 | DR REDDYS LABS INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076710 | SUPPL-12 | DR REDDYS LABS INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076710 | SUPPL-13 | DR REDDYS LABS INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076890 | SUPPL-8 | CIPLA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076890 | SUPPL-9 | CIPLA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076890 | SUPPL-13 | CIPLA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #076890 | SUPPL-14 | CIPLA LTD | Labeling | Approval |
| April 24 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077417 | SUPPL-7 | ACTAVIS LABS FL INC | Labeling | Approval |
| April 24 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077701 | SUPPL-13 | DR REDDYS LABS LTD | Labeling | Approval |
| April 24 | CIPROFLOXACIN EXTENDED RELEASE ANDA #077809 | SUPPL-7 | ACTAVIS LABS FL INC | Labeling | Approval |
| April 24 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078712 | SUPPL-4 | FOSUN PHARMA | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #090787 | SUPPL-6 | APOTEX INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #090787 | SUPPL-7 | APOTEX INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #090787 | SUPPL-8 | APOTEX INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #090787 | SUPPL-9 | APOTEX INC | Labeling | Approval |
| April 24 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #200674 | SUPPL-4 | FRESENIUS KABI USA | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #201043 | SUPPL-11 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #201043 | SUPPL-12 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #201043 | SUPPL-14 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #201043 | SUPPL-15 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #201043 | SUPPL-16 | AUROBINDO PHARMA LTD | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #202801 | SUPPL-1 | HETERO LABS LTD V | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #202801 | SUPPL-3 | HETERO LABS LTD V | Labeling | Approval |
| April 24 | LEVOFLOXACIN ANDA #202801 | SUPPL-4 | HETERO LABS LTD V | Labeling | Approval |
| April 24 | TESTOSTERONE ANDA #204255 | SUPPL-2 | PERRIGO ISRAEL | Labeling | Approval |
| April 24 | TESTOSTERONE ANDA #204255 | SUPPL-3 | PERRIGO ISRAEL | Labeling | Approval |
| April 24 | TESTOSTERONE CYPIONATE ANDA #206368 | ORIG-1 | WILSHIRE PHARMS INC | Approval | |
| April 24 | ROSUVASTATIN CALCIUM ANDA #206381 | ORIG-1 | SCIEGEN PHARMS INC | Approval | |
| April 24 | PENTAMIDINE ISETHIONATE ANDA #206667 | ORIG-1 | SETON PHARMS | Approval | |
| April 24 | PROMACTA KIT NDA #207027 | SUPPL-8 | NOVARTIS PHARMS CORP | Labeling | Approval |
| April 24 | CISATRACURIUM BESYLATE ANDA #209132 | ORIG-1 | SOMERSET THERAPS LLC | Approval | |
| April 24 | TERIFLUNOMIDE ANDA #209623 | ORIG-1 | MSN LABS PVT LTD | Approval | |
| April 24 | BUMETANIDE ANDA #209916 | SUPPL-1 | UPSHER SMITH LABS | Labeling | Approval |
| April 24 | MEDROXY-PROGESTERONE ACETATE ANDA #210761 | ORIG-1 | SUN PHARM | Approval | |
| April 24 | METHYLPHENIDATE HYDROCHLORIDE ANDA #211918 | ORIG-1 | ANDOR PHARMS | Approval | |
| April 24 | LEFLUNOMIDE ANDA #212308 | ORIG-1 | ZYDUS | Approval | |
| April 25 | PROTONIX NDA #020987 | SUPPL-55 | WYETH PHARMS | Labeling | Approval |
| April 25 | PROTONIX IV NDA #020988 | SUPPL-61 | WYETH PHARMS | Labeling | Approval |
| April 25 | VELCADE NDA #021602 | SUPPL-44 | MILLENNIUM PHARMS | Efficacy | Approval |
| April 25 | PROTONIX NDA #022020 | SUPPL-17 | WYETH PHARMS | Labeling | Approval |
| April 25 | CEFTIN NDA #050605 | SUPPL-51 | GLAXOSMITHKLINE | Labeling | Approval |
| April 25 | CEFTIN NDA #050672 | SUPPL-37 | GLAXOSMITHKLINE | Labeling | Approval |
| April 25 | IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #091370 | SUPPL-8 | ALEMBIC PHARMS LTD | Labeling | Approval |
| April 25 | IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #091370 | SUPPL-13 | ALEMBIC PHARMS LTD | Labeling | Approval |
| April 25 | DAUNORUBICIN HYDROCHLORIDE ANDA #206195 | ORIG-1 | HISUN PHARM HANGZHOU | Approval | |
| April 25 | CLARITHROMYCIN ANDA #206714 | ORIG-1 | AJANTA PHARMA LTD | Approval | |
| April 25 | DUOBRII NDA #209354 | ORIG-1 | BAUSCH HEALTH AMERICAS INC | Type 5 - New Formulation or New Manufacturer | Approval |
| April 25 | LINEZOLID ANDA #210702 | ORIG-1 | CELLTRION | Approval | |
| April 25 | CISATRACURIUM BESYLATE PRESERVATIVE FREE ANDA #211668 | ORIG-1 | NANJING KING-FRIEND | Approval | |
| April 25 | CISATRACURIUM BESYLATE ANDA #211669 | ORIG-1 | NANJING KING-FRIEND | Approval | |
| April 25 | ETICOVO BLA #761066 | ORIG-1 | SAMSUNG BIOEPIS CO LTD | Approval | |
| April 26 | CARDIOGEN-82 NDA #019414 | SUPPL-22 | BRACCO | Labeling | Approval |
| April 26 | TRACLEER NDA #021290 | SUPPL-32 | ACTELION PHARMS LTD | REMS | Approval |
| April 26 | LEVOFLOXACIN ANDA #076276 | SUPPL-5 | MYLAN | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #076276 | SUPPL-6 | MYLAN | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #076276 | SUPPL-7 | MYLAN | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #076361 | SUPPL-10 | TEVA | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #077438 | SUPPL-11 | SANDOZ | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #077438 | SUPPL-12 | SANDOZ | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #077438 | SUPPL-15 | SANDOZ | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #077438 | SUPPL-16 | SANDOZ | Labeling | Approval |
| April 26 | CIPROFLOXACIN ANDA #077782 | SUPPL-16 | TEVA PHARMS USA | Labeling | Approval |
| April 26 | CIPROFLOXACIN ANDA #077782 | SUPPL-18 | TEVA PHARMS USA | Labeling | Approval |
| April 26 | CIPROFLOXACIN ANDA #077782 | SUPPL-19 | TEVA PHARMS USA | Labeling | Approval |
| April 26 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078166 | SUPPL-12 | ANCHEN PHARMS | Labeling | Approval |
| April 26 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078183 | SUPPL-18 | MYLAN PHARMS INC | Labeling | Approval |
| April 26 | CIPROFLOXACIN EXTENDED RELEASE ANDA #078183 | SUPPL-20 | MYLAN PHARMS INC | Labeling | Approval |
| April 26 | BENLYSTA BLA #125370 | SUPPL-64 | HUMAN GENOME SCIENCES INC. | Approval | |
| April 26 | PRALUENT BLA #125559 | SUPPL-19 | SANOFI AVENTIS | Approval | |
| April 26 | PRALUENT BLA #125559 | SUPPL-20 | SANOFI AVENTIS | Approval | |
| April 26 | EZETIMIBE ANDA #201790 | ORIG-1 | MYLAN | Approval | |
| April 26 | RUBY-FILL NDA #202153 | SUPPL-12 | JUBILANT DRAXIMAGE | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #202200 | SUPPL-4 | ORCHID HLTHCARE | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #202200 | SUPPL-5 | ORCHID HLTHCARE | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #202200 | SUPPL-6 | ORCHID HLTHCARE | Labeling | Approval |
| April 26 | LEVOFLOXACIN ANDA #202200 | SUPPL-7 | ORCHID HLTHCARE | Labeling | Approval |
| April 26 | NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #205588 | SUPPL-3 | LUPIN LTD | Labeling | Approval |
| April 26 | BOSENTAN ANDA #205699 | ORIG-1 | PAR PHARM INC | Approval | |
| April 26 | BOSENTAN ANDA #206002 | ORIG-1 | ALVOGEN PINE BROOK | Approval | |
| April 26 | BOSENTAN ANDA #206987 | ORIG-1 | NATCO PHARMA LTD | Approval | |
| April 26 | BOSENTAN ANDA #207110 | ORIG-1 | WATSON LABS INC | Approval | |
| April 26 | BOSENTAN ANDA #207760 | ORIG-1 | ZYDUS PHARMS | Approval | |
| April 26 | BOSENTAN ANDA #208695 | ORIG-1 | WEST-WARD PHARMS INT | Approval | |
| April 26 | TRACLEER NDA #209279 | SUPPL-4 | ACTELION PHARMS | REMS | Approval |
| April 26 | BOSENTAN ANDA #209324 | ORIG-1 | SUN PHARM | Approval | |
| April 26 | AZACITIDINE ANDA #209540 | SUPPL-1 | CIPLA | Labeling | Approval |
| April 26 | BOSENTAN ANDA #209742 | ORIG-1 | AMNEAL PHARMS CO | Approval | |
| April 26 | POTASSIUM CHLORIDE ANDA #210098 | ORIG-1 | PII | Approval | |
| April 26 | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #210507 | ORIG-1 | UNICHEM LABS LTD | Tentative Approval | |
| April 26 | AMBRISENTAN ANDA #210715 | ORIG-1 | CIPLA | Approval | |
| April 26 | ZURAGARD NDA #210872 | ORIG-1 | ZUREX PHARMA | Type 5 - New Formulation or New Manufacturer | Approval |
| April 26 | TRIENTINE HYDROCHLORIDE ANDA #211554 | ORIG-1 | ZYDUS PHARMS | Approval | |
| April 26 | DICYCLOMINE HYDROCHLORIDE ANDA #212058 | ORIG-1 | SUNGEN PHARMA | Approval | |
| April 26 | BENLYSTA BLA #761043 | SUPPL-7 | GLAXOSMITHKLINE LLC | Approval | |
| April 27 | MERREM NDA #050706 | SUPPL-41 | PFIZER | Labeling | Approval |
| April 29 | ARGATROBAN IN SODIUM CHLORIDE NDA #022485 | SUPPL-13 | SANDOZ | Labeling | Approval |
| April 29 | PIRMELLA 7/7/7 ANDA #201510 | SUPPL-11 | LUPIN LTD | Manufacturing (CMC) | Approval |
| April 29 | PIRMELLA 1/35 ANDA #201512 | SUPPL-11 | LUPIN LTD | Manufacturing (CMC) | Approval |
| April 29 | KALYDECO NDA #203188 | SUPPL-29 | VERTEX PHARMS | Efficacy | Approval |
| April 29 | FELODIPINE ANDA #204800 | ORIG-1 | YUNG SHIN PHARM | Approval | |
| April 29 | TADALAFIL ANDA #206956 | ORIG-1 | MYLAN | Approval | |
| April 29 | TADALAFIL ANDA #206957 | ORIG-1 | MYLAN | Approval | |
| April 29 | KALYDECO NDA #207925 | SUPPL-8 | VERTEX PHARMS INC | Efficacy | Approval |
| April 29 | OLOPATADINE HYDROCHLORIDE ANDA #209420 | ORIG-1 | ALEMBIC PHARMS LTD | Approval | |
| April 29 | VANCOMYCIN HYDROCHLORIDE ANDA #210729 | ORIG-1 | ORIENT PHARMA CO LTD | Approval | |
| April 30 | VFEND NDA #021266 | SUPPL-45 | PF PRISM CV | Labeling | Approval |
| April 30 | VFEND NDA #021267 | SUPPL-55 | PF PRISM CV | Labeling | Approval |
| April 30 | VESICARE NDA #021518 | SUPPL-18 | ASTELLAS | Labeling | Approval |
| April 30 | VFEND NDA #021630 | SUPPL-34 | PF PRISM CV | Labeling | Approval |
| April 30 | INTUNIV NDA #022037 | SUPPL-18 | SHIRE | Labeling | Approval |
| April 30 | BICILLIN C-R NDA #050138 | SUPPL-240 | KING PHARMS LLC | Labeling | Approval |
| April 30 | BICILLIN C-R 900/300 NDA #050138 | SUPPL-240 | KING PHARMS LLC | Labeling | Approval |
| April 30 | BICILLIN L-A NDA #050141 | SUPPL-237 | KING PHARMS LLC | Labeling | Approval |
| April 30 | OFLOXACIN ANDA #076182 | SUPPL-17 | TEVA | Labeling | Approval |
| April 30 | PROLIA BLA #125320 | SUPPL-200 | AMGEN | Approval | |
| April 30 | XGEVA BLA #125320 | SUPPL-200 | AMGEN | Approval | |
| April 30 | MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER ANDA #205833 | SUPPL-6 | MYLAN LABS LTD | Labeling | Approval |
| April 30 | E-Z-CAT DRY NDA #208036 | SUPPL-10 | BRACCO | Efficacy | Approval |
| April 30 | E-Z-HD NDA #208036 | SUPPL-10 | BRACCO | Efficacy | Approval |
| April 30 | E-Z-PAQUE NDA #208036 | SUPPL-10 | BRACCO | Efficacy | Approval |
| April 30 | LUMIFY NDA #208144 | SUPPL-2 | BAUSCH AND LOMB INC | Labeling | Approval |
| April 30 | SELENIOUS ACID NDA #209379 | ORIG-1 | AMERICAN REGENT INC | Type 2 - New Active Ingredient | Approval |
| April 30 | MAVYRET NDA #209394 | SUPPL-6 | ABBVIE INC | Efficacy | Approval |
| April 30 | BOSUTINIB ANDA #209577 | ORIG-1 | SUN PHARM INDUSTRIES | Tentative Approval | |
| April 30 | POTASSIUM CHLORIDE ANDA #209922 | ORIG-1 | PRINSTON INC | Approval | |
| April 30 | NITROGLYCERIN ANDA #211604 | ORIG-1 | ALVOGEN MALTA | Approval |
