The U.S. Food and Drug Administration approved 227 drug products in June, 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 June
| Approval Date | Drug Name | Submission | Active Ingredients | Company | Submission Classification | Submission Status |
| June 3 | MIRALAX NDA #022015 | SUPPL-35 | POLYETHYLENE GLYCOL 3350 | BAYER HEALTHCARE LLC | Labeling | Approval |
| June 3 | TESTOSTERONE ANDA #076737 | SUPPL-9 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| June 3 | TESTOSTERONE ANDA #076737 | SUPPL-13 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| June 3 | TESTOSTERONE ANDA #076744 | SUPPL-8 | TESTOSTERONE | PAR PHARM | Labeling | Approval |
| June 3 | TESTOSTERONE ANDA #076744 | SUPPL-9 | TESTOSTERONE | PAR PHARM | Labeling | Approval |
| June 3 | TESTOSTERONE ANDA #076744 | SUPPL-10 | TESTOSTERONE | PAR PHARM | Labeling | Approval |
| June 3 | LANSOPRAZOLE ANDA #201921 | SUPPL-6 | LANSOPRAZOLE | NATCO PHARMA LTD | Labeling | Approval |
| June 3 | ELIQUIS NDA #202155 | SUPPL-21 | APIXABAN | BRISTOL MYERS SQUIBB | Labeling | Approval |
| June 3 | ZYTIGA NDA #202379 | SUPPL-27 | ABIRATERONE ACETATE | JANSSEN BIOTECH | Labeling | Approval |
| June 3 | ZYTIGA NDA #202379 | SUPPL-28 | ABIRATERONE ACETATE | JANSSEN BIOTECH | Efficacy | Approval |
| June 3 | BROMFENAC SODIUM ANDA #203368 | ORIG-1 | BROMFENAC SODIUM | INNOPHARMA LICENSING | Approval | |
| June 3 | ZERBAXA NDA #206829 | SUPPL-8 | CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM | CUBIST PHARMS LLC | Efficacy | Approval |
| June 3 | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE ANDA #206894 | ORIG-1 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | CIPLA | Approval | |
| June 3 | ERLOTINIB ANDA #208396 | ORIG-1 | ERLOTINIB | APOTEX INC | Tentative Approval | |
| June 3 | TESTOSTERONE ANDA #208560 | SUPPL-1 | TESTOSTERONE | LUPIN ATLANTIS | Labeling | Approval |
| June 3 | LEFLUNOMIDE ANDA #212453 | ORIG-1 | LEFLUNOMIDE | ABHAI LLC | Approval | |
| June 4 | TESTOSTERONE ANDA #208061 | SUPPL-2 | TESTOSTERONE | LUPIN LTD | REMS | Approval |
| June 4 | TESTOSTERONE ANDA #208620 | SUPPL-1 | TESTOSTERONE | DR REDDYS | Labeling | Approval |
| June 4 | TESTOSTERONE ANDA #208620 | SUPPL-2 | TESTOSTERONE | DR REDDYS | Labeling | Approval |
| June 4 | TESTOSTERONE ANDA #209533 | SUPPL-4 | TESTOSTERONE | CIPLA | REMS | Approval |
| June 4 | RANOLAZINE ANDA #211829 | ORIG-1 | RANOLAZINE | SCIEGEN PHARMS INC | Approval | |
| June 4 | EMGALITY BLA #761063 | SUPPL-3 | GALCANEZUMAB-GNLM | ELI LILLY AND CO | Approval | |
| June 5 | ESOMEPRAZOLE MAGNESIUM ANDA #209716 | ORIG-1 | ESOMEPRAZOLE MAGNESIUM | AMNEAL PHARMS NY | Approval | |
| June 5 | CARBIDOPA AND LEVODOPA ANDA #210341 | ORIG-1 | CARBIDOPA; LEVODOPA | ALEMBIC PHARMS LTD | Approval | |
| June 6 | TAXOTERE NDA #020449 | SUPPL-80 | DOCETAXEL | SANOFI AVENTIS US | Labeling | Approval |
| June 6 | TAXOTERE NDA #020449 | SUPPL-82 | DOCETAXEL | SANOFI AVENTIS US | Labeling | Approval |
| June 6 | NUCALA BLA #125526 | SUPPL-13 | MEPOLIZUMAB | GLAXOSMITHKLINE LLC | Approval | |
| June 6 | ANORO ELLIPTA NDA #203975 | SUPPL-10 | UMECLIDINIUM BROMIDE;
VILANTEROL TRIFENATATE | GLAXOSMITHKLINE | Efficacy | Approval |
| June 6 | INCRUSE ELLIPTA NDA #205382 | SUPPL-10 | UMECLIDINIUM BROMIDE | GLAXO GRP ENGLAND | Efficacy | Approval |
| June 6 | DESMOPRESSIN ACETATE ANDA
#208357 | ORIG-1 | DESMOPRESSIN ACETATE | NOVAST LABS | Approval | |
| June 6 | NUCALA BLA #761122 | ORIG-1 | MEPOLIZUMAB | GLAXOSMITHKLINE | Approval | |
| June 7 | THALOMID NDA #020785 | SUPPL-67 | THALIDOMIDE | CELGENE | Labeling | Approval |
| June 7 | TINDAMAX NDA #021618 | SUPPL-6 | TINIDAZOLE | MISSION PHARMA | Labeling | Approval |
| June 7 | VIVITROL NDA #021897 | SUPPL-44 | NALTREXONE | ALKERMES | REMS | Approval |
| June 7 | EMFLAZA NDA #208684 | SUPPL-3 | DEFLAZACORT | PTC THERAP | Efficacy | Approval |
| June 7 | EMFLAZA NDA #208685 | SUPPL-3 | DEFLAZACORT | PTC THERAP | Efficacy | Approval |
| June 7 | TOFACITINIB ANDA #209633 | ORIG-1 | TOFACITINIB | BRECKENRIDGE PHARMS | Tentative Approval | |
| June 7 | DEXAMETHASONE SODIUM PHOSPHATE ANDA #210967 | ORIG-1 | DEXAMETHASONE SODIUM PHOSPHATE | AUROBINDO PHARMA LTD | Approval | |
| June 10 | KEYTRUDA BLA #125514 | SUPPL-52 | PEMBROLIZUMAB | MERCK SHARP DOHME | Approval | |
| June 10 | OPSUMIT NDA #204410 | SUPPL-19 | MACITENTAN | ACTELION PHARMS LTD | REMS | Approval |
| June 10 | ZEMBRACE SYMTOUCH NDA #208223 | SUPPL-5 | SUMATRIPTAN SUCCINATE | DR REDDYS | Efficacy | Approval |
| June 10 | NIACIN ANDA #212017 | ORIG-1 | NIACIN | YICHANG HUMANWELL | Approval | |
| June 10 | POLIVY BLA #761121 | ORIG-1 | POLATUZUMAB VEDOTIN-PIIQ | GENENTECH | Approval | |
| June 11 | FURADANTIN NDA #009175 | SUPPL-46 | NITROFURANTOIN | CASPER PHARMA LLC | Labeling | Approval |
| June 11 | PEPCID COMPLETE NDA #020958 | SUPPL-29 | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | J AND J CONSUMER INC | Labeling | Approval |
| June 11 | MEN'S ROGAINE NDA #021812 | SUPPL-14 | MINOXIDIL | JOHNSON AND JOHNSON | Labeling | Approval |
| June 11 | WOMEN'S ROGAINE NDA #021812 | SUPPL-14 | MINOXIDIL | JOHNSON AND JOHNSON | Labeling | Approval |
| June 11 | NUEDEXTA NDA #021879 | SUPPL-14 | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE
SULFATE | AVANIR PHARMS | Labeling | Approval |
| June 11 | VIMPAT NDA #022253 | SUPPL-45 | LACOSAMIDE | UCB INC | Labeling | Approval |
| June 11 | VIMPAT NDA #022254 | SUPPL-35 | LACOSAMIDE | UCB INC | Labeling | Approval |
| June 11 | VIMPAT NDA #022255 | SUPPL-26 | LACOSAMIDE | UCB INC | Labeling | Approval |
| June 11 | PROGRAF NDA #050708 | SUPPL-50 | TACROLIMUS | ASTELLAS | Labeling | Approval |
| June 11 | PROGRAF NDA #050709 | SUPPL-42 | TACROLIMUS | ASTELLAS | Labeling | Approval |
| June 11 | ACTEMRA BLA #125276 | SUPPL-127 | TOCILIZUMAB | GENENTECH | Approval | |
| June 11 | ACTEMRA BLA #125472 | SUPPL-40 | TOCILIZUMAB | GENENTECH | Approval | |
| June 11 | QUETIAPINE FUMARATE ANDA #202939 | SUPPL-2 | QUETIAPINE FUMARATE | INTELLIPHARMACEUTICS | Manufacturing (CMC) | Approval |
| June 11 | ASTAGRAF XL NDA #204096 | SUPPL-7 | TACROLIMUS | ASTELLAS | Labeling | Approval |
| June 11 | TESTOSTERONE ANDA #205328 | SUPPL-2 | TESTOSTERONE | ACTAVIS LABS UT INC | REMS | Approval |
| June 11 | TIGECYCLINE ANDA #206335 | ORIG-1 | TIGECYCLINE | AUROBINDO PHARMA LTD | Approval | |
| June 11 | POTASSIUM CHLORIDE ANDA #209026 | ORIG-1 | POTASSIUM CHLORIDE | PRINSTON INC | Approval | |
| June 11 | PROGRAF NDA #210115 | SUPPL-2 | TACROLIMUS | ASTELLAS | Labeling | Approval |
| June 11 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ANDA #210663 | ORIG-1 | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | BRECKENRIDGE PHARM | Approval | |
| June 12 | DIOVAN HCT NDA #020818 | SUPPL-75 | HYDROCHLOROTHIAZIDE; VALSARTAN | NOVARTIS | Labeling | Approval |
| June 12 | DIOVAN NDA #021283 | SUPPL-53 | VALSARTAN | NOVARTIS | Labeling | Approval |
| June 12 | EXFORGE NDA #021990 | SUPPL-33 | AMLODIPINE BESYLATE; VALSARTAN | NOVARTIS | Labeling | Approval |
| June 12 | EXFORGE HCT NDA #022314 | SUPPL-27 | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | NOVARTIS | Labeling | Approval |
| June 12 | BUPROPION HYDROCHLORIDE ANDA #077284 | SUPPL-42 | BUPROPION HYDROCHLORIDE | ANCHEN PHARMS | Labeling | Approval |
| June 12 | MESALAMINE ANDA #202065 | ORIG-1 | MESALAMINE | SANDOZ INC | Approval | |
| June 12 | PALIPERIDONE ANDA #204452 | ORIG-1 | PALIPERIDONE | INVENTIA HLTHCARE | Approval | |
| June 12 | LORATADINE ANDA #210033 | ORIG-1 | LORATADINE | PERRIGO PHARMA INTL | Approval | |
| June 12 | DAPAGLIFLOZIN ANDA #211545 | ORIG-1 | DAPAGLIFLOZIN | ALKEM LABS LTD | Tentative Approval | |
| June 12 | BUPRENORPHINE HYDROCHLORIDE ANDA #211594 | ORIG-1 | BUPRENORPHINE HYDROCHLORIDE | ALVOGEN MALTA | Tentative Approval | |
| June 12 | VANCOMYCIN HYDROCHLORIDE ANDA #212332 | ORIG-1 | VANCOMYCIN HYDROCHLORIDE | HAINAN POLY PHARM | Approval | |
| June 13 | CLEOCIN HYDROCHLORIDE NDA
#050162 | SUPPL-101 | CLINDAMYCIN HYDROCHLORIDE | PHARMACIA AND UPJOHN | Labeling | Approval |
| June 13 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE ANDA #205295 | ORIG-1 | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | FDC LTD | Approval | |
| June 13 | NUZYRA NDA #209816 | SUPPL-2 | OMADACYCLINE TOSYLATE | PARATEK PHARMS INC | Labeling | Approval |
| June 13 | NUZYRA NDA #209816 | SUPPL-3 | OMADACYCLINE TOSYLATE | PARATEK PHARMS INC | Labeling | Approval |
| June 13 | NUZYRA NDA #209816 | SUPPL-4 | OMADACYCLINE TOSYLATE | PARATEK PHARMS INC | Labeling | Approval |
| June 13 | NUZYRA NDA #209817 | SUPPL-1 | OMADACYCLINE TOSYLATE | PARATEK PHARMS INC | Labeling | Approval |
| June 13 | NUZYRA NDA #209817 | SUPPL-2 | OMADACYCLINE TOSYLATE | PARATEK PHARMS INC | Labeling | Approval |
| June 13 | NUZYRA NDA #209817 | SUPPL-3 | OMADACYCLINE TOSYLATE | PARATEK PHARMS INC | Labeling | Approval |
| June 13 | BUDESONIDE NDA #211929 | ORIG-1 | BUDESONIDE | SUN PHARMA GLOBAL | Type 5 - New Formulation or New Manufacturer | Approval |
| June 13 | AMJEVITA BLA #761024 | SUPPL-4 | ADALIMUMAB-ATTO | AMGEN INC | Approval | |
| June 13 | KANJINTI BLA #761073 | ORIG-1 | TRASTUZUMAB-ANNS | AMGEN INC | Approval | |
| June 14 | LOTRISONE NDA #018827 | SUPPL-50 | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | MERCK SHARP DOHME | Labeling | Approval |
| June 14 | TRAMADOL HYDROCHLORIDE ANDA #202075 | SUPPL-2 | TRAMADOL HYDROCHLORIDE | ACI HEALTHCARE LTD | REMS | Approval |
| June 14 | APTENSIO XR NDA #205831 | SUPPL-5 | METHYLPHENIDATE
HYDROCHLORIDE | RHODES PHARMS | Efficacy | Approval |
| June 14 | DILTIAZEM HYDROCHLORIDE ANDA #208783 | ORIG-1 | DILTIAZEM HYDROCHLORIDE | NOVAST LABS | Approval | |
| June 14 | OMEGA-3-ACID ETHYL ESTERS ANDA #210107 | ORIG-1 | OMEGA-3-ACID ETHYL ESTERS | ZYDUS | Approval | |
| June 17 | CHILDREN'S CLARITIN NDA #021891 | SUPPL-31 | LORATADINE | BAYER HEALTHCARE LLC | Labeling | Approval |
| June 17 | CLARITIN NDA #021891 | SUPPL-31 | LORATADINE | BAYER HEALTHCARE LLC | Labeling | Approval |
| 6/17/2019 | VICTOZA NDA #022341 | SUPPL-31 | LIRAGLUTIDE RECOMBINANT | NOVO NORDISK INC | Efficacy | Approval |
| 6/17/2019 | KEYTRUDA BLA #125514 | SUPPL-53 | PEMBROLIZUMAB | MERCK SHARP DOHME | Approval | |
| 6/17/2019 | SPINRAZA NDA #209531 | SUPPL-7 | NUSINERSEN SODIUM | BIOGEN IDEC | Labeling | Approval |
| 6/17/2019 | SPINRAZA NDA #209531 | SUPPL-8 | NUSINERSEN SODIUM | BIOGEN IDEC | Labeling | Approval |
| 6/17/2019 | POTASSIUM CHLORIDE ANDA #210097 | ORIG-1 | POTASSIUM CHLORIDE | PII | Approval | |
| June 18 | RAPAMUNE NDA #021083 | SUPPL-66 | SIROLIMUS | PF PRISM CV | Labeling | Approval |
| June 18 | HALOPERIDOL DECANOATE ANDA #075305 | SUPPL-22 | HALOPERIDOL DECANOATE | WEST-WARD PHARMS INT | Manufacturing (CMC) | Approval |
| June 18 | INFLECTRA BLA #125544 | SUPPL-9 | INFLIXIMAB-DYYB | CELLTRION INC | Approval | |
| June 18 | ACETAZOLAMIDE ANDA #203917 | ORIG-1 | ACETAZOLAMIDE | MYLAN | Approval | |
| June 18 | ONZETRA XSAIL NDA #206099 | SUPPL-5 | SUMATRIPTAN SUCCINATE | AVANIR PHARMS | Labeling | Approval |
| June 18 | DICLOFENAC SODIUM ANDA #208786 | ORIG-1 | DICLOFENAC SODIUM | MYLAN LABS LTD | Approval | |
| June 18 | BIKTARVY NDA #210251 | SUPPL-5 | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | GILEAD SCIENCES INC | Efficacy | Approval |
| June 18 | XERAVA NDA #211109 | SUPPL-1 | ERAVACYCLINE DIHYDROCHLORIDE | TETRAPHASE PHARMS | Manufacturing (CMC) | Approval |
| June 19 | QUALAQUIN NDA #021799 | SUPPL-29 | QUININE SULFATE | SUN PHARM INDUSTRIES | Labeling | Approval |
| June 19 | CLEOCIN PHOSPHATE NDA #050441 | SUPPL-81 | CLINDAMYCIN PHOSPHATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| June 19 | CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #050639 | SUPPL-40 | CLINDAMYCIN PHOSPHATE | PHARMACIA AND UPJOHN | Labeling | Approval |
| June 19 | SCOPOLAMINE ANDA #203753 | ORIG-1 | SCOPOLAMINE | MYLAN TECHNOLOGIES | Approval | |
| June 19 | MYCOPHENOLATE MOFETIL ANDA #204077 | SUPPL-1 | MYCOPHENOLATE MOFETIL | ZHEJIANG HISUN PHARM | Manufacturing (CMC) | Approval |
| June 19 | OTREXUP NDA #204824 | SUPPL-9 | METHOTREXATE | ANTARES PHARMA INC | Labeling | Approval |
| June 19 | OTREXUP PFS NDA #204824 | SUPPL-9 | METHOTREXATE | ANTARES PHARMA INC | Labeling | Approval |
| June 19 | BIMATOPROST ANDA #207601 | ORIG-1 | BIMATOPROST | SOMERSET THERAPS LLC | Approval | |
| June 19 | LUBIPROSTONE ANDA #209450 | ORIG-1 | LUBIPROSTONE | AMNEAL PHARMS NY | Tentative Approval | |
| June 19 | IVERMECTIN ANDA #210225 | ORIG-1 | IVERMECTIN | PERRIGO UK FINCO | Tentative Approval | |
| June 19 | CLINDAMYCIN PHOSPHATE ANDA
#210778 | ORIG-1 | CLINDAMYCIN PHOSPHATE | GLENMARK PHARMS LTD | Tentative Approval | |
| June 20 | POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER NDA #019904 | SUPPL-20 | POTASSIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| June 20 | POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER NDA #019904 | SUPPL-20 | POTASSIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| June 20 | POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER NDA #019904 | SUPPL-20 | POTASSIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| June 20 | POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER NDA #019904 | SUPPL-20 | POTASSIUM CHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| June 20 | TRISENOX NDA #021248 | SUPPL-18 | ARSENIC TRIOXIDE | CEPHALON | Labeling | Approval |
| June 20 | BOTOX BLA #103000 | SUPPL-5309 | OnabotulinumtoxinA | ALLERGAN | Approval | |
| June 20 | BOTOX COSMETIC BLA #103000 | SUPPL-5309 | OnabotulinumtoxinA | ALLERGAN | Approval | |
| June 20 | AVASTIN BLA #125085 | SUPPL-331 | BEVACIZUMAB | GENENTECH | Approval | |
| June 20 | KETOROLAC TROMETHAMINE ANDA #203492 | ORIG-1 | KETOROLAC TROMETHAMINE | MICRO LABS LTD INDIA | Tentative Approval | |
| June 20 | MYXREDLIN NDA #208157 | ORIG-1 | INSULIN HUMAN; SODIUM CHLORIDE | CELERITY PHARMS | Type 5 - New Formulation or New Manufacturer | Approval |
| June 20 | DEXTENZA NDA #208742 | SUPPL-1 | DEXAMETHASONE | OCULAR THERAPEUTIX | Efficacy | Approval |
| June 20 | SODIUM BICARBONATE ANDA #211091 | ORIG-1 | SODIUM BICARBONATE | EXELA PHARMA SCS LLC | Approval | |
| June 20 | GANCICLOVIR SODIUM ANDA #212001 | ORIG-1 | GANCICLOVIR SODIUM | CUSTOPHARM INC | Approval | |
| June 21 | COLAZAL NDA #020610 | SUPPL-21 | BALSALAZIDE DISODIUM | VALEANT PHARMS INTL | Labeling | Approval |
| June 21 | TESTOSTERONE ANDA #091073 | SUPPL-2 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| June 21 | GEMCITABINE HYDROCHLORIDE NDA #200795 | SUPPL-10 | GEMCITABINE HYDROCHLORIDE | HOSPIRA INC | Labeling | Approval |
| June 21 | DOCETAXEL NDA #201195 | SUPPL-13 | DOCETAXEL | ACCORD HLTHCARE | Labeling | Approval |
| June 21 | TESTOSTERONE ANDA #204571 | SUPPL-3 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| June 21 | TESTOSTERONE ANDA #204571 | SUPPL-5 | TESTOSTERONE | ACTAVIS LABS UT INC | Labeling | Approval |
| June 21 | CAPECITABINE ANDA #204668 | ORIG-1 | CAPECITABINE | SUN PHARM | Approval | |
| June 21 | DEXTROAMPHETAMINE SULFATE ANDA #205077 | ORIG-1 | DEXTROAMPHETAMINE SULFATE | PII | Approval | |
| June 21 | LINEZOLID ANDA #205442 | SUPPL-1 | LINEZOLID | HOSPIRA INC | Labeling | Approval |
| June 21 | LINEZOLID ANDA #205442 | SUPPL-2 | LINEZOLID | HOSPIRA INC | Labeling | Approval |
| June 21 | TESTOSTERONE ANDA #207373 | SUPPL-1 | TESTOSTERONE | AMNEAL PHARMS LLC | Labeling | Approval |
| June 21 | MESALAMINE ANDA #208362 | ORIG-1 | MESALAMINE | AMRING PHARMS | Approval | |
| June 21 | SYMDEKO (COPACKAGED) NDA #210491 | SUPPL-3 | IVACAFTOR; IVACAFTOR,
TEZACAFTOR | VERTEX PHARMS INC | Efficacy | Approval |
| June 21 | VYLEESI NDA #210557 | ORIG-1 | BREMELANOTIDE ACETATE | AMAG PHARMS INC | Type 1 - New Molecular Entity | Approval |
| June 21 | BROMFENAC SODIUM ANDA #210560 | ORIG-1 | BROMFENAC SODIUM | ALEMBIC PHARMS LTD | Approval | |
| June 21 | ROFLUMILAST ANDA #212490 | ORIG-1 | ROFLUMILAST | ALKEM LABS LTD | Tentative Approval | |
| June 24 | TOPOTECAN HYDROCHLORIDE NDA #022453 | SUPPL-11 | TOPOTECAN HYDROCHLORIDE | TEVA PHARMS USA | Labeling | Approval |
| June 24 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ANDA #091348 | SUPPL-10 | SULFAMETHOXAZOLE;
TRIMETHOPRIM | AUROBINDO PHARMA | Manufacturing (CMC) | Approval |
| June 24 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #091629 | SUPPL-20 | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | AUROBINDO PHARMA | Labeling | Approval |
| June 24 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #201682 | SUPPL-6 | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | IPCA LABS LTD | Labeling | Approval |
| June 24 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #202289 | SUPPL-12 | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | MACLEODS PHARMS LTD | Labeling | Approval |
| June 24 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #204832 | SUPPL-3 | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | UNICHEM LABS LTD | Labeling | Approval |
| June 24 | LONHALA MAGNAIR KIT NDA #208437 | SUPPL-3 | GLYCOPYRROLATE | SUNOVION RESP | Labeling | Approval |
| June 24 | PENICILLAMINE ANDA #210976 | ORIG-1 | PENICILLAMINE | WATSON LABS INC | Approval | |
| June 24 | OSELTAMIVIR PHOSPHATE ANDA #211823 | ORIG-1 | OSELTAMIVIR PHOSPHATE | ALEMBIC PHARMS LTD | Approval | |
| June 24 | Apremilast ANDA #211878 | ORIG-1 | APREMILAST | ANNORA | Tentative Approval | |
| June 24 | DAPTOMYCIN ANDA #211961 | ORIG-1 | DAPTOMYCIN | ACCORD HLTHCARE | Approval | |
| June 24 | MVASI BLA #761028 | SUPPL-4 | BEVACIZUMAB-AWWB | AMGEN INC | Approval | |
| June 25 | XALKORI NDA #202570 | SUPPL-28 | CRIZOTINIB | PF PRISM CV | Labeling | Approval |
| June 25 | BORTEZOMIB ANDA #202963 | ORIG-1 | BORTEZOMIB | DR REDDYS LABS LTD | Tentative Approval | |
| June 25 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE ANDA #207523 | ORIG-1 | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | SOMERSET THERAPS LLC | Approval | |
| June 25 | GEMCITABINE HYDROCHLORIDE NDA #209604 | SUPPL-4 | GEMCITABINE HYDROCHLORIDE | ACCORD HLTHCARE | Labeling | Approval |
| June 25 | SPRAVATO NDA #211243 | SUPPL-2 | ESKETAMINE HYDROCHLORIDE | JANSSEN PHARMS | REMS | Approval |
| June 26 | ZAVESCA NDA #021348 | SUPPL-15 | MIGLUSTAT | ACTELION PHARMS LTD | Labeling | Approval |
| June 26 | CLOPIDOGREL BISULFATE ANDA #077665 | SUPPL-8 | CLOPIDOGREL BISULFATE | MYLAN PHARMS INC | Labeling | Approval |
| June 26 | LINEZOLID ANDA #200222 | SUPPL-4 | LINEZOLID | TEVA PHARMS | Labeling | Approval |
| June 26 | CLOPIDOGREL BISULFATE ANDA #202928 | SUPPL-8 | CLOPIDOGREL BISULFATE | MACLEODS PHARMS LTD | Labeling | Approval |
| June 26 | CLOPIDOGREL BISULFATE ANDA #202928 | SUPPL-9 | CLOPIDOGREL BISULFATE | MACLEODS PHARMS LTD | Labeling | Approval |
| June 26 | CLOPIDOGREL BISULFATE ANDA #202928 | SUPPL-11 | CLOPIDOGREL BISULFATE | MACLEODS PHARMS LTD | Labeling | Approval |
| June 26 | CLOPIDOGREL BISULFATE ANDA #202928 | SUPPL-14 | CLOPIDOGREL BISULFATE | MACLEODS PHARMS LTD | Labeling | Approval |
| June 26 | CLOPIDOGREL BISULFATE ANDA #202928 | SUPPL-15 | CLOPIDOGREL BISULFATE | MACLEODS PHARMS LTD | Labeling | Approval |
| June 26 | ATORVASTATIN CALCIUM ANDA #208478 | ORIG-1 | ATORVASTATIN CALCIUM | PERRIGO R AND D | Tentative Approval | |
| June 26 | DOXYCYCLINE HYCLATE ANDA #208818 | SUPPL-1 | DOXYCYCLINE HYCLATE | LUPIN LTD | Labeling | Approval |
| June 26 | MIRABEGRON ANDA #209485 | ORIG-1 | MIRABEGRON | LUPIN LTD | Tentative Approval | |
| June 26 | DAPSONE ANDA #210191 | ORIG-1 | DAPSONE | TARO PHARMS | Approval | |
| June 26 | DOPTELET NDA #210238 | SUPPL-1 | AVATROMBOPAG MALEATE | AKARX INC | Efficacy | Approval |
| June 26 | FEBUXOSTAT ANDA #210461 | ORIG-1 | FEBUXOSTAT | MSN LABORATORIES | Tentative Approval | |
| June 26 | TOBRAMYCIN ANDA #210915 | ORIG-1 | TOBRAMYCIN | TEVA PHARMS USA | Approval | |
| June 26 | DAPAGLIFLOZIN ANDA #211467 | ORIG-1 | DAPAGLIFLOZIN | MICRO LABS LTD | Tentative Approval | |
| June 26 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ANDA #212231 | ORIG-1 | SULFAMETHOXAZOLE;
TRIMETHOPRIM | SOMERSET THERAPS LLC | Approval | |
| June 26 | DAPTOMYCIN ANDA #212513 | ORIG-1 | DAPTOMYCIN | BE PHARMS | Approval | |
| June 26 | RENFLEXIS BLA #761054 | SUPPL-9 | INFLIXIMAB-ABDA | SAMSUNG BIOEPIS CO LTD | Approval | |
| June 26 | DUPIXENT BLA #761055 | SUPPL-14 | DUPILUMAB | REGENERON PHARMACEUTICALS | Approval | |
| June 27 | FLUDEOXYGLUCOSE F18 NDA #021870 | SUPPL-15 | FLUDEOXYGLUCOSE F-18 | FEINSTEIN | Labeling | Approval |
| June 27 | SOLIRIS BLA #125166 | SUPPL-431 | ECULIZUMAB | ALEXION PHARM | Approval | |
| June 27 | TESTOSTERONE ANDA #204268 | SUPPL-4 | TESTOSTERONE | PERRIGO ISRAEL | Labeling | Approval |
| June 27 | LINEZOLID ANDA #205154 | SUPPL-1 | LINEZOLID | MYLAN LABS LTD | Labeling | Approval |
| June 27 | LINEZOLID ANDA #205154 | SUPPL-3 | LINEZOLID | MYLAN LABS LTD | Labeling | Approval |
| June 27 | TESTOSTERONE ANDA #205781 | SUPPL-4 | TESTOSTERONE | PERRIGO UK FINCO | Labeling | Approval |
| June 27 | LINEZOLID ANDA #206917 | SUPPL-1 | LINEZOLID | AUROBINDO PHARMA LTD | Labeling | Approval |
| June 27 | EZETIMIBE AND SIMVASTATIN ANDA #208699 | ORIG-1 | EZETIMIBE; SIMVASTATIN | GLENMARK PHARMS LTD | Approval | |
| June 27 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ANDA #211546 | ORIG-1 | AMPHETAMINE ASPARTATE;AMPHETAMINE SULFATE;DEXTROAMPHETAMINE SACCHARATE;DEXTROAMPHETAMINE SULFATE | SPECGX LLC | Tentative Approval | |
| June 27 | ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #211610 | ORIG-1 | ACETAMINOPHEN; CODEINE PHOSPHATE | WES PHARMA INC | Approval | |
| June 27 | METHYLPREDNISOLONE ANDA #212262 | ORIG-1 | METHYLPREDNISOLONE | SUNGEN PHARMA | Approval | |
| June 27 | DARZALEX BLA #761036 | SUPPL-20 | DARATUMUMAB | JANSSEN BIOTECH | Approval | |
| June 27 | ZIRABEV BLA #761099 | ORIG-1 | BEVACIZUMAB-BVZR | PFIZER INC | Approval | |
| June 28 | ANTIVERT NDA #010721 | SUPPL-63 | MECLIZINE HYDROCHLORIDE | CASPER PHARMA LLC | Efficacy | Approval |
| June 28 | THIOLA NDA #019569 | SUPPL-6 | TIOPRONIN | MISSION PHARMA | Labeling | Approval |
| June 28 | LEVAQUIN NDA #020634 | SUPPL-71 | LEVOFLOXACIN | JANSSEN PHARMS | Labeling | Approval |
| June 28 | ERY-TAB ANDA #062298 | SUPPL-72 | ERYTHROMYCIN | ARBOR PHARMS LLC | Labeling | Approval |
| June 28 | MINOCYCLINE HYDROCHLORIDE ANDA #065485 | SUPPL-11 | MINOCYCLINE HYDROCHLORIDE | BARR LABS INC | Labeling | Approval |
| June 28 | FLUCONAZOLE ANDA #077253 | SUPPL-14 | FLUCONAZOLE | GLENMARK GENERICS | Labeling | Approval |
| June 28 | FLUCONAZOLE ANDA #077253 | SUPPL-16 | FLUCONAZOLE | GLENMARK GENERICS | Labeling | Approval |
| June 28 | FLUCONAZOLE ANDA #077253 | SUPPL-17 | FLUCONAZOLE | GLENMARK GENERICS | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #090041 | SUPPL-5 | MEMANTINE HYDROCHLORIDE | AMNEAL PHARMS | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #090043 | SUPPL-6 | MEMANTINE HYDROCHLORIDE | UPSHER SMITH LABS | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #090051 | SUPPL-2 | MEMANTINE HYDROCHLORIDE | LUPIN LTD | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #090244 | SUPPL-1 | MEMANTINE HYDROCHLORIDE | APOTEX INC | Labeling | Approval |
| June 28 | LANSOPRAZOLE ANDA #090331 | SUPPL-16 | LANSOPRAZOLE | SANDOZ | Labeling | Approval |
| June 28 | LANSOPRAZOLE ANDA #090331 | SUPPL-18 | LANSOPRAZOLE | SANDOZ | Labeling | Approval |
| June 28 | LANSOPRAZOLE ANDA #090331 | SUPPL-19 | LANSOPRAZOLE | SANDOZ | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #090961 | SUPPL-1 | MEMANTINE HYDROCHLORIDE | CADILA | Labeling | Approval |
| June 28 | LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #091264 | SUPPL-8 | LEVOCETIRIZINE DIHYDROCHLORIDE | HETERO LABS LTD III | Labeling | Approval |
| June 28 | LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #091264 | SUPPL-10 | LEVOCETIRIZINE DIHYDROCHLORIDE | HETERO LABS LTD III | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #202840 | SUPPL-9 | MEMANTINE HYDROCHLORIDE | MACLEODS PHARMS LTD | Labeling | Approval |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #203175 | SUPPL-4 | MEMANTINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | Labeling | Approval |
| June 28 | VORICONAZOLE ANDA #203503 | SUPPL-1 | VORICONAZOLE | GLENMARK PHARMS LTD | Labeling | Approval |
| June 28 | VORICONAZOLE ANDA #203503 | SUPPL-2 | VORICONAZOLE | GLENMARK PHARMS LTD | Labeling | Approval |
| June 28 | VORICONAZOLE ANDA #203503 | SUPPL-3 | VORICONAZOLE | GLENMARK PHARMS LTD | Labeling | Approval |
| June 28 | TRANEXAMIC ACID ANDA #203521 | SUPPL-10 | TRANEXAMIC ACID | EMCURE PHARMS LTD | Labeling | Approval |
| June 28 | LINEZOLID ANDA #204696 | SUPPL-2 | LINEZOLID | SAGENT PHARMS | Labeling | Approval |
| June 28 | PEMETREXED ANDA #205238 | ORIG-1 | PEMETREXED | SUN PHARM INDS LTD | Tentative Approval | |
| June 28 | MEMANTINE HYDROCHLORIDE ANDA #206855 | SUPPL-1 | MEMANTINE HYDROCHLORIDE | PURACAP PHARM LLC | Labeling | Approval |
| June 28 | TRAMADOL HYDROCHLORIDE ANDA #208708 | ORIG-1 | TRAMADOL HYDROCHLORIDE | RUBICON | Approval | |
| June 28 | CINACALCET HYDROCHLORIDE ANDA #210548 | ORIG-1 | CINACALCET HYDROCHLORIDE | LUPIN LTD | Approval | |
| June 28 | CLONAZEPAM ANDA #211033 | ORIG-1 | CLONAZEPAM | ALEMBIC PHARMS LTD | Approval | |
| June 28 | ISOPROTERENOL HYDROCHLORIDE ANDA #211738 | ORIG-1 | ISOPROTERENOL HYDROCHLORIDE | CIPLA | Approval | |
| June 28 | THIOLA EC NDA #211843 | ORIG-1 | TIOPRONIN | MISSION PHARMACAL CO | Type 3 - New Dosage Form | Approval |
| June 28 | OGIVRI BLA #761074 | SUPPL-5 | TRASTUZUMAB-DKST | MYLAN GMBH | Approval |
