Drugs@FDA: FDA-Approved Drugs

All Approvals and Tentative Approvals
March 2021

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on March 06, 2021.

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Approval Date	Drug Name	Submission	Active Ingredients	Company	Submission Classification *	Submission Status
03/01/2021	XANAX NDA #018276	SUPPL-55	ALPRAZOLAM	UPJOHN	Labeling	Approval
03/01/2021	PLAVIX NDA #020839	SUPPL-74	CLOPIDOGREL BISULFATE	SANOFI AVENTIS US	Labeling	Approval
03/01/2021	XANAX XR NDA #021434	SUPPL-18	ALPRAZOLAM	UPJOHN	Labeling	Approval
03/01/2021	BUPROPION HYDROCHLORIDE ANDA #203969	SUPPL-2	BUPROPION HYDROCHLORIDE	TORRENT	Labeling	Approval
03/01/2021	BUPROPION HYDROCHLORIDE ANDA #203969	SUPPL-4	BUPROPION HYDROCHLORIDE	TORRENT	Labeling	Approval
03/01/2021	FLUDEOXYGLUCOSE F18 ANDA #204463	SUPPL-1	FLUDEOXYGLUCOSE F-18	DECATUR	Labeling	Approval
03/01/2021	FLUOXETINE HYDROCHLORIDE ANDA #204597	SUPPL-11	FLUOXETINE HYDROCHLORIDE	SCIEGEN PHARMS INC	Labeling	Approval
03/01/2021	TRIUMEQ NDA #205551	SUPPL-25	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE	VIIV HLTHCARE	Efficacy	Approval
03/01/2021	FIRDAPSE NDA #208078	SUPPL-7	AMIFAMPRIDINE PHOSPHATE	CATALYST PHARMS	Labeling	Approval
03/01/2021	HYDROCODONE BITARTRATE ANDA #208269	ORIG-1	HYDROCODONE BITARTRATE	ALVOGEN PINE BROOK		Approval
03/01/2021	DEFERASIROX ANDA #210945	SUPPL-2	DEFERASIROX	MSN	Manufacturing (CMC)	Approval
03/01/2021	DEFERASIROX ANDA #210945	SUPPL-3	DEFERASIROX	MSN	Labeling	Approval
03/01/2021	DEFERASIROX ANDA #210945	SUPPL-5	DEFERASIROX	MSN	Labeling	Approval
03/01/2021	IBRUTINIB ANDA #211350	ORIG-1	IBRUTINIB	TEVA PHARMS USA INC		Tentative Approval
03/01/2021	LEVORPHANOL TARTRATE ANDA #211484	SUPPL-2	LEVORPHANOL TARTRATE	VIRTUS PHARMS	Labeling	Approval
03/01/2021	DOXEPIN HYDROCHLORIDE ANDA #211618	ORIG-1	DOXEPIN HYDROCHLORIDE	LEADING PHARMA LLC		Approval
03/01/2021	DOVATO NDA #211994	SUPPL-10	DOLUTEGRAVIR SODIUM; LAMIVUDINE	VIIV HLTHCARE	Efficacy	Approval
03/01/2021	FLUPHENAZINE HYDROCHLORIDE ANDA #214674	ORIG-1	FLUPHENAZINE HYDROCHLORIDE	NOVITIUM PHARMA		Approval
03/02/2021	H.P. ACTHAR GEL NDA #008372	SUPPL-68	CORTICOTROPIN	MALLINCKRODT ARD	Labeling	Approval
03/02/2021	LOZOL NDA #018538	SUPPL-30	INDAPAMIDE	SANOFI AVENTIS US	Labeling	Approval
03/02/2021	ZIAC NDA #020186	SUPPL-37	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE	TEVA BRANDED PHARM	Labeling	Approval
03/02/2021	ZEMPLAR NDA #020819	SUPPL-36	PARICALCITOL	ABBVIE	Labeling	Approval
03/02/2021	CHILDREN'S CLARITIN NDA #021891	SUPPL-37	LORATADINE	BAYER HEALTHCARE LLC	Labeling	Approval
03/02/2021	CLARITIN NDA #021891	SUPPL-37	LORATADINE	BAYER HEALTHCARE LLC	Labeling	Approval
03/02/2021	SPIRONOLACTONE ANDA #205936	SUPPL-2	SPIRONOLACTONE	ZYDUS PHARMS	Labeling	Approval
03/02/2021	AZSTARYS NDA #212994	ORIG-1	SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE	COMMCAVE THERAPEUTICS SA	Type 1 - New Molecular Entity and Type 4 - New Combination	Approval
03/03/2021	BUSPIRONE HYDROCHLORIDE ANDA #075521	SUPPL-10	BUSPIRONE HYDROCHLORIDE	RUBICON	Labeling	Approval
03/03/2021	CARBAMAZEPINE ANDA #075712	SUPPL-29	CARBAMAZEPINE	TORRENT PHARMS	Labeling	Approval
03/03/2021	CARBAMAZEPINE ANDA #075712	SUPPL-32	CARBAMAZEPINE	TORRENT PHARMS	Labeling	Approval
03/03/2021	VALGANCICLOVIR HYDROCHLORIDE ANDA #205151	ORIG-1	VALGANCICLOVIR HYDROCHLORIDE	MYLAN		Approval
03/03/2021	HYDROMORPHONE HYDROCHLORIDE ANDA #205629	SUPPL-7	HYDROMORPHONE HYDROCHLORIDE	OSMOTICA	Labeling	Approval
03/03/2021	HYDROMORPHONE HYDROCHLORIDE ANDA #205629	SUPPL-11	HYDROMORPHONE HYDROCHLORIDE	OSMOTICA	Labeling	Approval
03/03/2021	ZEJULA NDA #208447	SUPPL-19	NIRAPARIB TOSYLATE	GLAXOSMITHKLINE	Labeling	Approval
03/03/2021	ZEJULA NDA #208447	SUPPL-20	NIRAPARIB TOSYLATE	GLAXOSMITHKLINE	Labeling	Approval
03/03/2021	OXALIPLATIN ANDA #208523	SUPPL-1	OXALIPLATIN	CIPLA	Labeling	Approval
03/03/2021	LORBRENA NDA #210868	SUPPL-4	LORLATINIB	PFIZER	Efficacy	Approval
03/03/2021	METHADONE HYDROCHLORIDE ANDA #212094	ORIG-1	METHADONE HYDROCHLORIDE	LANNETT CO INC		Approval
03/03/2021	FOSAPREPITANT DIMEGLUMINE ANDA #212143	ORIG-1	FOSAPREPITANT DIMEGLUMINE	CHIA TAI TIANQING		Approval
03/03/2021	TESTOSTERONE ANDA #213922	ORIG-1	TESTOSTERONE	ALEOR DERMACEUTICALS		Approval
03/03/2021	GUANFACINE HYDROCHLORIDE ANDA #214689	ORIG-1	GUANFACINE HYDROCHLORIDE	UNICHEM		Approval
03/04/2021	DEMEROL NDA #005010	SUPPL-59	MEPERIDINE HYDROCHLORIDE	VALIDUS PHARMS	Labeling	Approval
03/04/2021	MS CONTIN NDA #019516	SUPPL-57	MORPHINE SULFATE	PURDUE PHARMA LP	Labeling	Approval
03/04/2021	DURAGESIC-100 NDA #019813	SUPPL-81	FENTANYL	JANSSEN PHARMS	Labeling	Approval
03/04/2021	DURAGESIC-12 NDA #019813	SUPPL-81	FENTANYL	JANSSEN PHARMS	Labeling	Approval
03/04/2021	DURAGESIC-25 NDA #019813	SUPPL-81	FENTANYL	JANSSEN PHARMS	Labeling	Approval
03/04/2021	DURAGESIC-37 NDA #019813	SUPPL-81	FENTANYL	JANSSEN PHARMS	Labeling	Approval
03/04/2021	DURAGESIC-50 NDA #019813	SUPPL-81	FENTANYL	JANSSEN PHARMS	Labeling	Approval
03/04/2021	DURAGESIC-75 NDA #019813	SUPPL-81	FENTANYL	JANSSEN PHARMS	Labeling	Approval
03/04/2021	DILAUDID NDA #019891	SUPPL-29	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
03/04/2021	DILAUDID NDA #019892	SUPPL-37	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
03/04/2021	FIORICET W/ CODEINE NDA #020232	SUPPL-45	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ACTAVIS LABS UT INC	Labeling	Approval
03/04/2021	ULTRAM NDA #020281	SUPPL-48	TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
03/04/2021	KADIAN NDA #020616	SUPPL-65	MORPHINE SULFATE	ALLERGAN	Labeling	Approval
03/04/2021	SUBUTEX NDA #020732	SUPPL-24	BUPRENORPHINE HYDROCHLORIDE	INDIVIOR INC	Labeling	Approval
03/04/2021	SUBOXONE NDA #020733	SUPPL-28	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	INDIVIOR INC	Labeling	Approval
03/04/2021	ACTIQ NDA #020747	SUPPL-53	FENTANYL CITRATE	CEPHALON	Labeling	Approval
03/04/2021	ROXICODONE NDA #021011	SUPPL-11	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
03/04/2021	ULTRACET NDA #021123	SUPPL-20	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
03/04/2021	BUTRANS NDA #021306	SUPPL-37	BUPRENORPHINE	PURDUE PHARMA LP	Labeling	Approval
03/04/2021	SYMBYAX NDA #021520	SUPPL-52	FLUOXETINE HYDROCHLORIDE; OLANZAPINE	LILLY	Labeling	Approval
03/04/2021	OPANA ER NDA #021610	SUPPL-28	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
03/04/2021	PATANASE NDA #021861	SUPPL-15	OLOPATADINE HYDROCHLORIDE	NOVARTIS	Labeling	Approval
03/04/2021	VIVITROL NDA #021897	SUPPL-52	NALTREXONE	ALKERMES	Labeling	Approval
03/04/2021	FENTORA NDA #021947	SUPPL-34	FENTANYL CITRATE	CEPHALON	Labeling	Approval
03/04/2021	MORPHINE SULFATE NDA #022195	SUPPL-19	MORPHINE SULFATE	HIKMA	Labeling	Approval
03/04/2021	MORPHINE SULFATE NDA #022207	SUPPL-10	MORPHINE SULFATE	HIKMA	Labeling	Approval
03/04/2021	ONSOLIS NDA #022266	SUPPL-25	FENTANYL CITRATE	BDSI	Labeling	Approval
03/04/2021	OXYCONTIN NDA #022272	SUPPL-46	OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	Labeling	Approval
03/04/2021	NUCYNTA NDA #022304	SUPPL-23	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
03/04/2021	CONZIP NDA #022370	SUPPL-20	TRAMADOL HYDROCHLORIDE	CIPHER PHARMS INC	Labeling	Approval
03/04/2021	CODEINE SULFATE NDA #022402	SUPPL-14	CODEINE SULFATE	HIKMA	Labeling	Approval
03/04/2021	SUBOXONE NDA #022410	SUPPL-42	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	INDIVIOR INC	Labeling	Approval
03/04/2021	LAZANDA NDA #022569	SUPPL-30	FENTANYL CITRATE	BTCP PHARMA	Labeling	Approval
03/04/2021	NUCYNTA ER NDA #200533	SUPPL-23	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
03/04/2021	OXYCODONE HYDROCHLORIDE NDA #200534	SUPPL-11	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	Labeling	Approval
03/04/2021	OXYCODONE HYDROCHLORIDE NDA #200535	SUPPL-19	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	Labeling	Approval
03/04/2021	OXYCODONE HYDROCHLORIDE NDA #201194	SUPPL-10	OXYCODONE HYDROCHLORIDE	VISTAPHARM	Labeling	Approval
03/04/2021	MORPHINE SULFATE NDA #201517	SUPPL-17	MORPHINE SULFATE	LANNETT CO INC	Labeling	Approval
03/04/2021	OXAYDO NDA #202080	SUPPL-12	OXYCODONE HYDROCHLORIDE	ZYLA	Labeling	Approval
03/04/2021	CODEINE SULFATE NDA #202245	SUPPL-9	CODEINE SULFATE	HIKMA	Labeling	Approval
03/04/2021	SUBSYS NDA #202788	SUPPL-23	FENTANYL	BTCP PHARMA	Labeling	Approval
03/04/2021	ZOHYDRO ER NDA #202880	SUPPL-20	HYDROCODONE BITARTRATE	PERSION	Labeling	Approval
03/04/2021	NUCYNTA NDA #203794	SUPPL-9	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
03/04/2021	ZUBSOLV NDA #204242	SUPPL-19	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	OREXO US INC	Labeling	Approval
03/04/2021	PROBUPHINE NDA #204442	SUPPL-11	BUPRENORPHINE HYDROCHLORIDE	TITAN PHARMS	Labeling	Approval
03/04/2021	BUNAVAIL NDA #205637	SUPPL-21	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	BDSI	Labeling	Approval
03/04/2021	HYSINGLA ER NDA #206627	SUPPL-12	HYDROCODONE BITARTRATE	PURDUE PHARMA LP	Labeling	Approval
03/04/2021	GENVOYA NDA #207561	SUPPL-25	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
03/04/2021	BELBUCA NDA #207932	SUPPL-15	BUPRENORPHINE HYDROCHLORIDE	BDSI	Labeling	Approval
03/04/2021	CASSIPA NDA #208042	SUPPL-4	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TEVA PHARMS USA	Labeling	Approval
03/04/2021	XTAMPZA ER NDA #208090	SUPPL-15	OXYCODONE	COLLEGIUM PHARM INC	Labeling	Approval
03/04/2021	DESCOVY NDA #208215	SUPPL-17	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
03/04/2021	ODEFSEY NDA #208351	SUPPL-11	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
03/04/2021	VEMLIDY NDA #208464	SUPPL-12	TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
03/04/2021	APADAZ NDA #208653	SUPPL-7	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	KVK TECH INC	Labeling	Approval
03/04/2021	ROXYBOND NDA #209777	SUPPL-7	OXYCODONE HYDROCHLORIDE	OHEMO LIFE	Labeling	Approval
03/04/2021	SUBLOCADE NDA #209819	SUPPL-17	BUPRENORPHINE	INDIVIOR INC	Labeling	Approval
03/04/2021	SUBLOCADE NDA #209819	SUPPL-18	BUPRENORPHINE	INDIVIOR INC	Labeling	Approval
03/04/2021	BIKTARVY NDA #210251	SUPPL-10	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Labeling	Approval
03/04/2021	OLINVYK NDA #210730	SUPPL-1	OLICERIDINE	TREVENA	Labeling	Approval

All Approvals and Tentative Approvals March 2021

All Approvals and Tentative Approvals
March 2021