Drugs@FDA: FDA-Approved Drugs

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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

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