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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 2020

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 September 19, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/01/2020 OMEPRAZOLE
ANDA #075410		 SUPPL-64 OMEPRAZOLE LANNETT CO INC Labeling Approval
12/01/2020 ROPINIROLE HYDROCHLORIDE
ANDA #079050		 SUPPL-5 ROPINIROLE HYDROCHLORIDE CHARTWELL RX Labeling Approval
12/01/2020 STELARA
BLA #125261		 SUPPL-154 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
12/01/2020 LIDOCAINE
ANDA #203265		 ORIG-1 LIDOCAINE NOVEN PHARMS INC Approval
12/01/2020 HETLIOZ
NDA #205677		 SUPPL-7 TASIMELTEON VANDA PHARMS INC Efficacy Approval
12/01/2020 FINACEA
NDA #207071		 SUPPL-2 AZELAIC ACID LEO PHARMA AS Labeling Approval
12/01/2020 FINACEA
NDA #207071		 SUPPL-4 AZELAIC ACID LEO PHARMA AS Labeling Approval
12/01/2020 DAUNORUBICIN HYDROCHLORIDE
ANDA #208759		 SUPPL-2 DAUNORUBICIN HYDROCHLORIDE HISUN PHARM HANGZHOU Manufacturing (CMC) Approval
12/01/2020 GALLIUM GA 68 GOZETOTIDE
NDA #212642		 ORIG-1 GALLIUM GA-68 GOZETOTIDE UNIV CA LOS ANGELES Type 1 - New Molecular Entity Approval
12/01/2020 GALLIUM GA 68 GOZETOTIDE
NDA #212643		 ORIG-1 GALLIUM GA-68 GOZETOTIDE UNIV OF CA SAN FRAN Type 1 - New Molecular Entity Approval
12/01/2020 HETLIOZ LQ
NDA #214517		 ORIG-1 TASIMELTEON VANDA PHARMS INC Type 3 - New Dosage Form Approval
12/01/2020 GAVRETO
NDA #214701		 ORIG-1 PRALSETINIB BLUEPRINT MEDICINES Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
12/01/2020 STELARA
BLA #761044		 SUPPL-6 USTEKINUMAB JANSSEN BIOTECH Approval
12/02/2020 FERRLECIT
NDA #020955		 SUPPL-19 FERRIC OXYHYDROXIDE SANOFI AVENTIS US Labeling Approval
12/02/2020 STAVUDINE
ANDA #079069		 SUPPL-5 STAVUDINE NORVIUM BIOSCIENCE Labeling Approval
12/02/2020 STAVUDINE
ANDA #079069		 SUPPL-7 STAVUDINE NORVIUM BIOSCIENCE Labeling Approval
12/02/2020 PREDNISONE INTENSOL
ANDA #088810		 SUPPL-29 PREDNISONE HIKMA Manufacturing (CMC) Approval
12/02/2020 LUMASON
NDA #203684		 SUPPL-7 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES BRACCO Labeling Approval
12/02/2020 GENVOYA
NDA #207561		 SUPPL-24 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
12/02/2020 AUSTEDO
NDA #208082		 SUPPL-7 DEUTETRABENAZINE TEVA BRANDED PHARM Labeling Approval
12/02/2020 ZILRETTA
NDA #208845		 SUPPL-11 TRIAMCINOLONE ACETONIDE PACIRA PHARMS INC Labeling Approval
12/02/2020 BYDUREON BCISE
NDA #209210		 SUPPL-14 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
12/02/2020 PENICILLAMINE
ANDA #211735		 ORIG-1 PENICILLAMINE GRANULES Approval
12/02/2020 METOLAZONE
ANDA #213251		 ORIG-1 METOLAZONE ALEMBIC Approval
12/02/2020 VIGABATRIN
ANDA #213375		 ORIG-1 VIGABATRIN ALKEM LABS LTD Approval
12/03/2020 CHILDREN'S ALLEGRA ALLERGY
NDA #021909		 SUPPL-15 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
12/03/2020 CHILDREN'S ALLEGRA HIVES
NDA #021909		 SUPPL-15 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
12/03/2020 TACROLIMUS
ANDA #090596		 SUPPL-10 TACROLIMUS MYLAN Labeling Approval
12/03/2020 TACROLIMUS
ANDA #090596		 SUPPL-12 TACROLIMUS MYLAN Labeling Approval
12/03/2020 TACROLIMUS
ANDA #090596		 SUPPL-15 TACROLIMUS MYLAN Labeling Approval
12/03/2020 TACROLIMUS
ANDA #090596		 SUPPL-17 TACROLIMUS MYLAN Labeling Approval
12/03/2020 POMALYST
NDA #204026		 SUPPL-28 POMALIDOMIDE BRISTOL Labeling Approval
12/03/2020 CELECOXIB
ANDA #205129		 ORIG-1 CELECOXIB SCIEGEN PHARMS INC Approval
12/03/2020 KETOROLAC TROMETHAMINE
ANDA #205190		 ORIG-1 KETOROLAC TROMETHAMINE EUGIA PHARMA Approval
12/03/2020 RITONAVIR
ANDA #205801		 ORIG-1 RITONAVIR HIKMA Approval
12/03/2020 MORPHINE SULFATE
ANDA #212451		 ORIG-1 MORPHINE SULFATE ALKEM LABS LTD Approval
12/03/2020 ORLADEYO
NDA #214094		 ORIG-1 BEROTRALSTAT HYDROCHLORIDE BIOCRYST Type 1 - New Molecular Entity Approval
12/04/2020 DEPO-PROVERA
NDA #020246		 SUPPL-60 MEDROXYPROGESTERONE ACETATE PFIZER Efficacy Approval
12/04/2020 DEPO-PROVERA
NDA #020246		 SUPPL-62 MEDROXYPROGESTERONE ACETATE PFIZER Efficacy Approval
12/04/2020 DEPO-SUBQ PROVERA 104
NDA #021583		 SUPPL-33 MEDROXYPROGESTERONE ACETATE PFIZER Efficacy Approval
12/04/2020 DEPO-SUBQ PROVERA 104
NDA #021583		 SUPPL-34 MEDROXYPROGESTERONE ACETATE PFIZER Efficacy Approval
12/04/2020 JANUVIA
NDA #021995		 SUPPL-47 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Efficacy Approval
12/04/2020 JANUMET
NDA #022044		 SUPPL-48 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Efficacy Approval
12/04/2020 JANUMET XR
NDA #202270		 SUPPL-22 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Efficacy Approval
12/04/2020 SUMATRIPTAN AND NAPROXEN SODIUM
ANDA #202803		 SUPPL-1 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE SUN PHARM Labeling Approval
12/04/2020 CAPECITABINE
ANDA #204345		 ORIG-1 CAPECITABINE DR REDDYS Approval
12/04/2020 RIVASTIGMINE
ANDA #204403		 SUPPL-4 RIVASTIGMINE ALVOGEN Labeling Approval
12/04/2020 RIVASTIGMINE
ANDA #204403		 SUPPL-6 RIVASTIGMINE ALVOGEN Labeling Approval
12/04/2020 NEXIUM 24HR
NDA #204655		 SUPPL-14 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #206125		 SUPPL-4 CINACALCET HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #206125		 SUPPL-6 CINACALCET HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/04/2020 SAXENDA
NDA #206321		 SUPPL-12 LIRAGLUTIDE NOVO Efficacy Approval
12/04/2020 SAXENDA
NDA #206321		 SUPPL-13 LIRAGLUTIDE NOVO Labeling Approval
12/04/2020 SAXENDA
NDA #206321		 SUPPL-14 LIRAGLUTIDE NOVO Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #207008		 SUPPL-4 CINACALCET HYDROCHLORIDE SUN PHARM Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #207008		 SUPPL-5 CINACALCET HYDROCHLORIDE SUN PHARM Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #208915		 SUPPL-3 CINACALCET HYDROCHLORIDE CIPLA Labeling Approval
12/04/2020 COLCHICINE
ANDA #209876		 SUPPL-3 COLCHICINE DR REDDYS Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #210548		 SUPPL-1 CINACALCET HYDROCHLORIDE LUPIN LTD Labeling Approval
12/04/2020 CINACALCET HYDROCHLORIDE
ANDA #210570		 SUPPL-1 CINACALCET HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
12/04/2020 COLESEVELAM HYDROCHLORIDE
ANDA #212050		 ORIG-1 COLESEVELAM HYDROCHLORIDE INVENTIA Approval
12/04/2020 TETRABENAZINE
ANDA #213621		 ORIG-1 TETRABENAZINE AJANTA PHARMA LTD Approval
12/05/2020 FRAGMIN
NDA #020287		 SUPPL-76 DALTEPARIN SODIUM PFIZER Labeling Approval
12/05/2020 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
NDA #050780		 SUPPL-20 CEFUROXIME SODIUM B BRAUN Labeling Approval
12/05/2020 REVCOVI
BLA #761092		 SUPPL-5 ELAPEGADEMASE-LVLR CHIESI USA INC Approval
12/07/2020 CETIRIZINE HYDROCHLORIDE ALLERGY
NDA #022429		 SUPPL-17 CETIRIZINE HYDROCHLORIDE BIONPHARMA Labeling Approval
12/07/2020 CETIRIZINE HYDROCHLORIDE HIVES RELIEF
NDA #022429		 SUPPL-17 CETIRIZINE HYDROCHLORIDE BIONPHARMA Labeling Approval
12/07/2020 LYSTEDA
NDA #022430		 SUPPL-9 TRANEXAMIC ACID AMRING PHARMS Labeling Approval
12/07/2020 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #078107		 SUPPL-4 FLUCONAZOLE WEST-WARD PHARMS INT Labeling Approval
12/07/2020 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #078107		 SUPPL-5 FLUCONAZOLE WEST-WARD PHARMS INT Labeling Approval
12/07/2020 ROPINIROLE HYDROCHLORIDE
ANDA #078881		 SUPPL-22 ROPINIROLE HYDROCHLORIDE NORVIUM BIOSCIENCE Labeling Approval
12/07/2020 AVYCAZ
NDA #206494		 SUPPL-7 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN Labeling Approval
12/07/2020 LYNPARZA
NDA #208558		 SUPPL-16 OLAPARIB ASTRAZENECA Efficacy Approval
12/07/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #210321		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Approval
12/07/2020 DECITABINE
ANDA #212117		 ORIG-1 DECITABINE NIVAGEN PHARMS INC Approval
12/08/2020 ZAVESCA
NDA #021348		 SUPPL-16 MIGLUSTAT ACTELION Labeling Approval
12/08/2020 TASIGNA
NDA #022068		 SUPPL-33 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
12/08/2020 BICILLIN C-R
NDA #050138		 SUPPL-243 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
12/08/2020 BICILLIN C-R 900/300
NDA #050138		 SUPPL-243 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
12/08/2020 BICILLIN L-A
NDA #050141		 SUPPL-239 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
12/08/2020 LOTEMAX
NDA #200738		 SUPPL-3 LOTEPREDNOL ETABONATE BAUSCH AND LOMB Labeling Approval
12/08/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #203939		 ORIG-1 FOSAPREPITANT DIMEGLUMINE SANDOZ Approval
12/08/2020 ZOLEDRONIC
ANDA #205749		 SUPPL-1 ZOLEDRONIC ACID GLAND PHARMA LTD Labeling Approval
12/08/2020 ZOLEDRONIC ACID
ANDA #205749		 SUPPL-1 ZOLEDRONIC ACID GLAND PHARMA LTD Labeling Approval
12/08/2020 CYANOCOBALAMIN
ANDA #213874		 ORIG-1 CYANOCOBALAMIN EUGIA PHARMA Approval
12/09/2020 ABSORICA
NDA #021951		 SUPPL-17 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070583		 SUPPL-30 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070583		 SUPPL-40 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070584		 SUPPL-29 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070584		 SUPPL-39 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070585		 SUPPL-30 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070585		 SUPPL-40 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070586		 SUPPL-20 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070586		 SUPPL-23 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070590		 SUPPL-26 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070590		 SUPPL-36 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070597		 SUPPL-27 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070597		 SUPPL-37 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070609		 SUPPL-23 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #070609		 SUPPL-26 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071165		 SUPPL-38 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071167		 SUPPL-37 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071168		 SUPPL-29 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071168		 SUPPL-31 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071168		 SUPPL-38 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
12/09/2020 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071170		 SUPPL-37 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
12/09/2020 AMNESTEEM
ANDA #075945		 SUPPL-39 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
12/09/2020 CLARAVIS
ANDA #076135		 SUPPL-50 ISOTRETINOIN TEVA PHARMS USA REMS Approval
12/09/2020 CLARAVIS
ANDA #076356		 SUPPL-45 ISOTRETINOIN TEVA PHARMS USA REMS Approval
12/09/2020 MYORISAN
ANDA #076485		 SUPPL-25 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
12/09/2020 ZIDOVUDINE
ANDA #077268		 SUPPL-19 ZIDOVUDINE AUROBINDO Labeling Approval
12/09/2020 OMEPRAZOLE
ANDA #078490		 SUPPL-16 OMEPRAZOLE DR REDDYS LABS LTD Labeling Approval
12/09/2020 AVASTIN
BLA #125085		 SUPPL-337 BEVACIZUMAB GENENTECH Approval
12/09/2020 ZENATANE
ANDA #202099		 SUPPL-21 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
12/09/2020 ISOTRETINOIN
ANDA #207792		 SUPPL-11 ISOTRETINOIN AMNEAL PHARMS NY REMS Approval
12/09/2020 EVEROLIMUS
ANDA #207934		 ORIG-2 EVEROLIMUS ENDO OPERATIONS Approval
12/09/2020 TAGRISSO
NDA #208065		 SUPPL-18 OSIMERTINIB MESYLATE ASTRAZENECA Efficacy Approval
12/09/2020 SYMPAZAN
NDA #210833		 SUPPL-1 CLOBAZAM OTTER PHARMS Labeling Approval
12/09/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #211160		 ORIG-1 FOSAPREPITANT DIMEGLUMINE DR REDDYS Approval
12/09/2020 ABSORICA LD
NDA #211913		 SUPPL-3 ISOTRETINOIN SUN PHARM REMS Approval
12/09/2020 CLOBAZAM
ANDA #211959		 ORIG-1 CLOBAZAM CELLTRION Approval
12/09/2020 CELECOXIB
ANDA #212925		 ORIG-1 CELECOXIB ACIC PHARMS Approval
12/10/2020 LOPID
NDA #018422		 SUPPL-59 GEMFIBROZIL PFIZER PHARMS Labeling Approval
12/10/2020 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020255		 SUPPL-22 DOBUTAMINE HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
12/10/2020 VPRIV
BLA #022575		 SUPPL-26 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
12/10/2020 BICILLIN C-R
NDA #050138		 SUPPL-242 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
12/10/2020 BICILLIN C-R 900/300
NDA #050138		 SUPPL-242 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
12/10/2020 BICILLIN L-A
NDA #050141		 SUPPL-238 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
12/10/2020 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #071251		 SUPPL-48 HYDROCHLOROTHIAZIDE; TRIAMTERENE APOTEX INC Labeling Approval
12/10/2020 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #072011		 SUPPL-39 HYDROCHLOROTHIAZIDE; TRIAMTERENE SANDOZ Labeling Approval
12/10/2020 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #073281		 SUPPL-35 HYDROCHLOROTHIAZIDE; TRIAMTERENE SANDOZ Labeling Approval
12/10/2020 MOMETASONE FUROATE
ANDA #076499		 SUPPL-15 MOMETASONE FUROATE ENCUBE Labeling Approval
12/10/2020 IRBESARTAN
ANDA #077466		 SUPPL-8 IRBESARTAN SANDOZ Labeling Approval
12/10/2020 MOMETASONE FUROATE
ANDA #090506		 SUPPL-4 MOMETASONE FUROATE GLENMARK PHARMS LTD Labeling Approval
12/10/2020 STIVARGA
NDA #203085		 SUPPL-14 REGORAFENIB BAYER HLTHCARE Manufacturing (CMC) Approval
12/10/2020 TRANEXAMIC ACID
ANDA #205035		 SUPPL-3 TRANEXAMIC ACID EUGIA PHARMA Labeling Approval
12/10/2020 MECLIZINE HYDROCHLORIDE
ANDA #205136		 SUPPL-2 MECLIZINE HYDROCHLORIDE WILSHIRE PHARMS INC Labeling Approval
12/10/2020 ASENAPINE MALEATE
ANDA #205960		 ORIG-1 ASENAPINE MALEATE BRECKENRIDGE Approval
12/10/2020 ASENAPINE MALEATE
ANDA #206098		 ORIG-1 ASENAPINE MALEATE ALEMBIC Approval
12/10/2020 ASENAPINE MALEATE
ANDA #206107		 ORIG-1 ASENAPINE MALEATE SIGMAPHARM LABS LLC Approval
12/10/2020 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #208360		 SUPPL-1 HYDROCHLOROTHIAZIDE; TRIAMTERENE ZYDUS PHARMS Labeling Approval
12/10/2020 DOXYCYCLINE HYCLATE
ANDA #209393		 ORIG-1 DOXYCYCLINE HYCLATE NOSTRUM LABS INC Approval
12/10/2020 SODIUM NITROPRUSSIDE
ANDA #211934		 ORIG-1 SODIUM NITROPRUSSIDE EUGIA PHARMA Approval
12/10/2020 TRANEXAMIC ACID
ANDA #212360		 SUPPL-2 TRANEXAMIC ACID CAPLIN Labeling Approval
12/10/2020 OMEPRAZOLE
ANDA #212977		 ORIG-1 OMEPRAZOLE XIROMED Approval
12/11/2020 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019615		 SUPPL-27 DOPAMINE HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
12/11/2020 AGGRASTAT
NDA #020913		 SUPPL-28 TIROFIBAN HYDROCHLORIDE MEDICURE Manufacturing (CMC) Approval
12/11/2020 RISPERIDONE
ANDA #076996		 SUPPL-1 RISPERIDONE ACTAVIS LABS FL INC Labeling Approval
12/11/2020 RISPERIDONE
ANDA #076996		 SUPPL-2 RISPERIDONE ACTAVIS LABS FL INC Labeling Approval
12/11/2020 MESNA
ANDA #090913		 SUPPL-6 MESNA SAGENT PHARMS INC Labeling Approval
12/11/2020 STELARA
BLA #125261		 SUPPL-157 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
12/11/2020 OMEPRAZOLE
ANDA #203481		 SUPPL-5 OMEPRAZOLE BRECKENRIDGE Labeling Approval
12/11/2020 TAGRISSO
NDA #208065		 SUPPL-19 OSIMERTINIB MESYLATE ASTRAZENECA Labeling Approval
12/11/2020 MEMANTINE HYDROCHLORIDE
ANDA #210587		 ORIG-1 MEMANTINE HYDROCHLORIDE POLYGEN PHARMS Approval
12/11/2020 GEMCITABINE HYDROCHLORIDE
ANDA #212129		 ORIG-1 GEMCITABINE HYDROCHLORIDE MEITHEAL Approval
12/11/2020 MIDAZOLAM HYDROCHLORIDE
ANDA #212847		 ORIG-1 MIDAZOLAM HYDROCHLORIDE HIKMA Approval
12/11/2020 STELARA
BLA #761044		 SUPPL-8 USTEKINUMAB JANSSEN BIOTECH Approval
12/12/2020 NAPROXEN SODIUM
NDA #021920		 SUPPL-33 NAPROXEN SODIUM BIONPHARMA Labeling Approval
12/12/2020 VOLTAREN ARTHRITIS PAIN
NDA #022122		 SUPPL-16 DICLOFENAC SODIUM HALEON US HOLDINGS Labeling Approval
12/14/2020 AZACITIDINE
ANDA #207475		 SUPPL-4 AZACITIDINE ACCORD HLTHCARE Labeling Approval
12/14/2020 ABIRATERONE ACETATE
ANDA #208446		 SUPPL-4 ABIRATERONE ACETATE MYLAN Manufacturing (CMC) Approval
12/14/2020 DARUNAVIR ETHANOLATE
ANDA #210187		 ORIG-1 DARUNAVIR ETHANOLATE MICRO LABS USA Tentative Approval
12/14/2020 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #211059		 ORIG-1 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE AUROBINDO PHARMA LTD Approval
12/14/2020 AMINOCAPROIC ACID
ANDA #211629		 ORIG-1 AMINOCAPROIC ACID ANI PHARMS Approval
12/14/2020 CLOFARABINE
ANDA #212034		 SUPPL-2 CLOFARABINE ACCORD HLTHCARE Labeling Approval
12/14/2020 KLISYRI
NDA #213189		 ORIG-1 TIRBANIBULIN ALMIRALL Type 1 - New Molecular Entity Approval
12/14/2020 OCREVUS
BLA #761053		 SUPPL-22 OCRELIZUMAB GENENTECH INC Approval
12/15/2020 AVAPRO
NDA #020757		 SUPPL-71 IRBESARTAN SANOFI AVENTIS US Labeling Approval
12/15/2020 AVALIDE
NDA #020758		 SUPPL-76 HYDROCHLOROTHIAZIDE; IRBESARTAN SANOFI AVENTIS US Labeling Approval
12/15/2020 LOTRIMIN ULTRA
NDA #021307		 SUPPL-18 BUTENAFINE HYDROCHLORIDE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
12/15/2020 CADUET
NDA #021540		 SUPPL-47 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
12/15/2020 RAPAFLO
NDA #022206		 SUPPL-16 SILODOSIN ALLERGAN Labeling Approval
12/15/2020 SEVELAMER HYDROCHLORIDE
ANDA #201068		 ORIG-1 SEVELAMER HYDROCHLORIDE RISING Approval
12/15/2020 TERIFLUNOMIDE
ANDA #209623		 SUPPL-1 TERIFLUNOMIDE MSN Labeling Approval
12/15/2020 TERIFLUNOMIDE
ANDA #209623		 SUPPL-2 TERIFLUNOMIDE MSN Labeling Approval
12/15/2020 NICOTINE POLACRILEX
ANDA #212796		 SUPPL-1 NICOTINE POLACRILEX DR REDDYS LABS SA Labeling Approval
12/15/2020 NICOTINE POLACRILEX
ANDA #212983		 SUPPL-1 NICOTINE POLACRILEX DR REDDYS LABS SA Labeling Approval
12/15/2020 NICOTINE POLACRILEX
ANDA #213233		 SUPPL-1 NICOTINE POLACRILEX DR REDDYS LABS SA Labeling Approval
12/15/2020 EPHEDRINE SULFATE
ANDA #214334		 ORIG-1 EPHEDRINE SULFATE HIKMA Approval
12/16/2020 NEURONTIN
NDA #020235		 SUPPL-69 GABAPENTIN VIATRIS Labeling Approval
12/16/2020 ALOPRIM
NDA #020298		 SUPPL-13 ALLOPURINOL SODIUM MYLAN Labeling Approval
12/16/2020 NEURONTIN
NDA #020882		 SUPPL-50 GABAPENTIN VIATRIS Labeling Approval
12/16/2020 NEURONTIN
NDA #021129		 SUPPL-50 GABAPENTIN VIATRIS Labeling Approval
12/16/2020 SYNERA
NDA #021623		 SUPPL-25 LIDOCAINE; TETRACAINE GALEN SPECIALTY Labeling Approval
12/16/2020 M.V.I. ADULT
NDA #021625		 SUPPL-24 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K HOSPIRA Labeling Approval
12/16/2020 VANTAS
NDA #021732		 SUPPL-23 HISTRELIN ACETATE ENDO OPERATIONS Labeling Approval
12/16/2020 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-21 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/16/2020 DULOXETINE HYDROCHLORIDE
ANDA #090778		 SUPPL-24 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/16/2020 HUMIRA
BLA #125057		 SUPPL-418 ADALIMUMAB ABBVIE INC Approval
12/16/2020 HUMIRA
BLA #125057		 SUPPL-419 ADALIMUMAB ABBVIE INC Approval
12/16/2020 BENLYSTA
BLA #125370		 SUPPL-73 BELIMUMAB HUMAN GENOME SCIENCES INC. Approval
12/16/2020 ACETYLCYSTEINE
ANDA #207358		 SUPPL-1 ACETYLCYSTEINE EUGIA PHARMA Labeling Approval
12/16/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207414		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE CHARTWELL MOLECULAR Approval
12/16/2020 FLUDEOXYGLUCOSE F18
ANDA #209341		 ORIG-1 FLUDEOXYGLUCOSE F-18 UNIV SOUTHERN CA Approval
12/16/2020 ETODOLAC
ANDA #210704		 ORIG-1 ETODOLAC BAYSHORE PHARMS LLC Approval
12/16/2020 TURALIO
NDA #211810		 SUPPL-6 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC REMS Approval
12/16/2020 EFINACONAZOLE
ANDA #211827		 ORIG-1 EFINACONAZOLE TEVA PHARMS USA Approval
12/16/2020 EFINACONAZOLE
ANDA #211851		 ORIG-1 EFINACONAZOLE PADAGIS US Approval
12/16/2020 ICATIBANT ACETATE
ANDA #212081		 ORIG-1 ICATIBANT ACETATE NANG KUANG PHARM CO Approval
12/16/2020 EMPAGLIFLOZIN
ANDA #212336		 ORIG-1 EMPAGLIFLOZIN DR REDDYS LABS LTD Tentative Approval
12/16/2020 DOXYCYCLINE HYCLATE
ANDA #214207		 ORIG-1 DOXYCYCLINE HYCLATE EPIC PHARMA LLC Approval
12/16/2020 BENLYSTA
BLA #761043		 SUPPL-13 BELIMUMAB GLAXOSMITHKLINE LLC Approval
12/16/2020 CABLIVI
BLA #761112		 SUPPL-7 CAPLACIZUMAB-YHDP ABLYNX NV Approval
12/16/2020 MARGENZA
BLA #761150		 ORIG-1 MARGETUXIMAB-CMKB MACROGENICS INC Approval
12/17/2020 ERTACZO
NDA #021385		 SUPPL-6 SERTACONAZOLE NITRATE LACER PHARMA Labeling Approval
12/17/2020 LIALDA
NDA #022000		 SUPPL-21 MESALAMINE TAKEDA PHARMS USA Labeling Approval
12/17/2020 MEPERIDINE HYDROCHLORIDE
ANDA #040331		 SUPPL-15 MEPERIDINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
12/17/2020 MEPERIDINE HYDROCHLORIDE
ANDA #040331		 SUPPL-17 MEPERIDINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
12/17/2020 MEPERIDINE HYDROCHLORIDE
ANDA #040331		 SUPPL-18 MEPERIDINE HYDROCHLORIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
12/17/2020 FLUVOXAMINE MALEATE
ANDA #075902		 SUPPL-21 FLUVOXAMINE MALEATE APOTEX Labeling Approval
12/17/2020 FLUVOXAMINE MALEATE
ANDA #075902		 SUPPL-24 FLUVOXAMINE MALEATE APOTEX Labeling Approval
12/17/2020 FOSPHENYTOIN SODIUM
ANDA #076886		 SUPPL-9 FOSPHENYTOIN SODIUM DR REDDYS Labeling Approval
12/17/2020 FOSPHENYTOIN SODIUM
ANDA #076886		 SUPPL-10 FOSPHENYTOIN SODIUM DR REDDYS Labeling Approval
12/17/2020 FOSPHENYTOIN SODIUM
ANDA #076886		 SUPPL-11 FOSPHENYTOIN SODIUM DR REDDYS Labeling Approval
12/17/2020 ACETYLCYSTEINE
ANDA #091684		 SUPPL-1 ACETYLCYSTEINE SAGENT PHARMS INC Labeling Approval
12/17/2020 EZETIMIBE AND SIMVASTATIN
ANDA #200082		 ORIG-1 EZETIMIBE; SIMVASTATIN AUROBINDO PHARMA USA Approval
12/17/2020 COLESEVELAM HYDROCHLORIDE
ANDA #201354		 ORIG-1 COLESEVELAM HYDROCHLORIDE CHARTWELL RX Approval
12/17/2020 PICATO
NDA #202833		 SUPPL-12 INGENOL MEBUTATE LEO LABS Labeling Approval
12/17/2020 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
ANDA #203433		 ORIG-1 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE HIKMA Approval
12/17/2020 ELEPSIA XR
NDA #204417		 SUPPL-4 LEVETIRACETAM TRIPOINT Labeling Approval
12/17/2020 OXYBUTYNIN CHLORIDE
ANDA #208165		 ORIG-1 OXYBUTYNIN CHLORIDE STRIDES PHARMA Approval
12/17/2020 DAPAGLIFLOZIN
ANDA #211414		 ORIG-1 DAPAGLIFLOZIN BIONPHARMA INC Tentative Approval
12/17/2020 RIABNI
BLA #761140		 ORIG-1 RITUXIMAB-ARRX AMGEN INC Approval
12/18/2020 ZANAFLEX
NDA #021447		 SUPPL-15 TIZANIDINE HYDROCHLORIDE LEGACY PHARMA USA Labeling Approval
12/18/2020 CILOSTAZOL
ANDA #077027		 SUPPL-19 CILOSTAZOL TEVA Labeling Approval
12/18/2020 KINERET
BLA #103950		 SUPPL-5189 ANAKINRA BIOVITRUM AB Approval
12/18/2020 ARCALYST
BLA #125249		 SUPPL-47 RILONACEPT KINIKSA PHARMACEUTICALS (UK), LTD. Approval
12/18/2020 Xeomin
BLA #125360		 SUPPL-86 incobotulinumtoxinA MERZ PHARMS Approval
12/18/2020 Xeomin
BLA #125360		 SUPPL-92 incobotulinumtoxinA MERZ PHARMS Approval
12/18/2020 JEVTANA KIT
NDA #201023		 SUPPL-24 CABAZITAXEL SANOFI AVENTIS US Efficacy Approval
12/18/2020 MODAFINIL
ANDA #202566		 SUPPL-5 MODAFINIL AUROBINDO PHARMA LTD Labeling Approval
12/18/2020 NYMALIZE
NDA #203340		 SUPPL-13 NIMODIPINE AZURITY Manufacturing (CMC) Approval
12/18/2020 ICLUSIG
NDA #203469		 SUPPL-34 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Efficacy Approval
12/18/2020 IMBRUVICA
NDA #205552		 SUPPL-32 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
12/18/2020 OLOPATADINE HYDROCHLORIDE
ANDA #206046		 SUPPL-2 OLOPATADINE HYDROCHLORIDE BAUSCH AND LOMB INC Labeling Approval
12/18/2020 LENVIMA
NDA #206947		 SUPPL-18 LENVATINIB MESYLATE EISAI INC Labeling Approval
12/18/2020 DABIGATRAN ETEXILATE MESYLATE
ANDA #207984		 ORIG-1 DABIGATRAN ETEXILATE MESYLATE GLENMARK PHARMS LTD Tentative Approval
12/18/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #207993		 ORIG-1 FINGOLIMOD HYDROCHLORIDE APOTEX Approval
12/18/2020 TAGRISSO
NDA #208065		 SUPPL-21 OSIMERTINIB MESYLATE ASTRAZENECA Efficacy Approval
12/18/2020 FUROSEMIDE
ANDA #208435		 ORIG-1 FUROSEMIDE AREVA PHARMS Approval
12/18/2020 IMBRUVICA
NDA #210563		 SUPPL-9 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
12/18/2020 VIZIMPRO
NDA #211288		 SUPPL-3 DACOMITINIB PFIZER Labeling Approval
12/18/2020 XPOVIO
NDA #212306		 SUPPL-5 SELINEXOR KARYOPHARM THERAPS Efficacy Approval
12/18/2020 MERZEE
ANDA #212706		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE WILSHIRE PHARMS INC Approval
12/18/2020 RUFINAMIDE
ANDA #213457		 ORIG-1 RUFINAMIDE LUPIN LTD Approval
12/18/2020 HYDRALAZINE HYDROCHLORIDE
ANDA #213667		 ORIG-1 HYDRALAZINE HYDROCHLORIDE HIKMA Approval
12/18/2020 ORGOVYX
NDA #214621		 ORIG-1 RELUGOLIX SUMITOMO PHARMA Type 1 - New Molecular Entity Approval
12/18/2020 ETOMIDATE
ANDA #215028		 ORIG-1 ETOMIDATE CAPLIN Approval
12/18/2020 TECENTRIQ
BLA #761034		 SUPPL-31 ATEZOLIZUMAB GENENTECH INC Approval
12/18/2020 TECENTRIQ
BLA #761034		 SUPPL-32 ATEZOLIZUMAB GENENTECH INC Approval
12/19/2020 PROHANCE
NDA #020131		 SUPPL-35 GADOTERIDOL BRACCO Efficacy Approval
12/19/2020 PROHANCE MULTIPACK
NDA #021489		 SUPPL-14 GADOTERIDOL BRACCO Efficacy Approval
12/19/2020 ABILIFY MYCITE KIT
NDA #207202		 SUPPL-3 ARIPIPRAZOLE OTSUKA Manufacturing (CMC) Approval
12/20/2020 ANECTINE
NDA #008453		 SUPPL-37 SUCCINYLCHOLINE CHLORIDE SANDOZ Labeling Approval
12/21/2020 TRUSOPT
NDA #020408		 SUPPL-52 DORZOLAMIDE HYDROCHLORIDE MSD SUB MERCK Labeling Approval
12/21/2020 TRILYTE
ANDA #076491		 SUPPL-12 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/21/2020 GRANISETRON HYDROCHLORIDE
ANDA #078197		 SUPPL-2 GRANISETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
12/21/2020 PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
ANDA #090019		 SUPPL-8 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE NOVEL LABS INC Labeling Approval
12/21/2020 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-15 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/21/2020 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-16 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/21/2020 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-17 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/21/2020 ZOLEDRONIC ACID
ANDA #091493		 SUPPL-5 ZOLEDRONIC ACID SAGENT PHARMS INC Labeling Approval
12/21/2020 ZOLEDRONIC ACID
ANDA #091493		 SUPPL-6 ZOLEDRONIC ACID SAGENT PHARMS INC Labeling Approval
12/21/2020 ZOLEDRONIC ACID
ANDA #091493		 SUPPL-7 ZOLEDRONIC ACID SAGENT PHARMS INC Labeling Approval
12/21/2020 ZOLEDRONIC ACID
ANDA #091493		 SUPPL-8 ZOLEDRONIC ACID SAGENT PHARMS INC Labeling Approval
12/21/2020 KALYDECO
NDA #203188		 SUPPL-34 IVACAFTOR VERTEX PHARMS Efficacy Approval
12/21/2020 XELPROS
NDA #206185		 SUPPL-9 LATANOPROST SUN PHARM Labeling Approval
12/21/2020 KALYDECO
NDA #207925		 SUPPL-13 IVACAFTOR VERTEX PHARMS INC Efficacy Approval
12/21/2020 SYMDEKO (COPACKAGED)
NDA #210491		 SUPPL-7 IVACAFTOR; IVACAFTOR, TEZACAFTOR VERTEX PHARMS INC Efficacy Approval
12/21/2020 BUPROPION HYDROCHLORIDE
ANDA #211347		 SUPPL-4 BUPROPION HYDROCHLORIDE YICHANG HUMANWELL Labeling Approval
12/21/2020 TRIKAFTA (COPACKAGED)
NDA #212273		 SUPPL-2 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR VERTEX PHARMS INC Efficacy Approval
12/21/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #214491		 ORIG-1 SUCCINYLCHOLINE CHLORIDE DEVA HOLDING AS Approval
12/21/2020 EBANGA
BLA #761172		 ORIG-1 ANSUVIMAB-ZYKL RIDGEBACK BIOTHERAPEUTICS Approval
12/22/2020 FUROSEMIDE
NDA #018569		 SUPPL-66 FUROSEMIDE EPIC PHARMA LLC Labeling Approval
12/22/2020 AMMONUL
NDA #020645		 SUPPL-12 SODIUM BENZOATE; SODIUM PHENYLACETATE BAUSCH Labeling Approval
12/22/2020 INVANZ
NDA #021337		 SUPPL-49 ERTAPENEM SODIUM MSD SUB MERCK Labeling Approval
12/22/2020 PREZISTA
NDA #021976		 SUPPL-59 DARUNAVIR JANSSEN PRODS Labeling Approval
12/22/2020 LETAIRIS
NDA #022081		 SUPPL-42 AMBRISENTAN GILEAD REMS Approval
12/22/2020 EFFIENT
NDA #022307		 SUPPL-18 PRASUGREL HYDROCHLORIDE COSETTE Labeling Approval
12/22/2020 AMPICILLIN TRIHYDRATE
ANDA #064082		 SUPPL-15 AMPICILLIN/AMPICILLIN TRIHYDRATE SANDOZ Labeling Approval
12/22/2020 IFOSFAMIDE
ANDA #076657		 SUPPL-29 IFOSFAMIDE MEITHEAL Labeling Approval
12/22/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920		 SUPPL-18 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
12/22/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202353		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
12/22/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202353		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
12/22/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202353		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE SANDOZ Labeling Approval
12/22/2020 PREZISTA
NDA #202895		 SUPPL-29 DARUNAVIR JANSSEN PRODS Labeling Approval
12/22/2020 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
ANDA #202912		 SUPPL-5 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
12/22/2020 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
ANDA #202912		 SUPPL-7 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
12/22/2020 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
ANDA #202912		 SUPPL-10 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
12/22/2020 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
ANDA #202912		 SUPPL-12 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE LUPIN LTD Labeling Approval
12/22/2020 PREZCOBIX
NDA #205395		 SUPPL-18 COBICISTAT; DARUNAVIR JANSSEN PRODS Labeling Approval
12/22/2020 IMBRUVICA
NDA #205552		 SUPPL-33 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
12/22/2020 BUPROPION HYDROCHLORIDE
ANDA #205794		 SUPPL-13 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
12/22/2020 BUPROPION HYDROCHLORIDE
ANDA #205794		 SUPPL-17 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
12/22/2020 AMBRISENTAN
ANDA #208252		 SUPPL-2 AMBRISENTAN WATSON LABS INC REMS Approval
12/22/2020 AMBRISENTAN
ANDA #208354		 SUPPL-2 AMBRISENTAN SIGMAPHARM LABS LLC REMS Approval
12/22/2020 AMBRISENTAN
ANDA #208441		 SUPPL-2 AMBRISENTAN MYLAN REMS Approval
12/22/2020 AMBRISENTAN
ANDA #209509		 SUPPL-2 AMBRISENTAN ENDO OPERATIONS REMS Approval
12/22/2020 AMBRISENTAN
ANDA #210058		 SUPPL-5 AMBRISENTAN ZYDUS PHARMS REMS Approval
12/22/2020 SYMTUZA
NDA #210455		 SUPPL-12 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE JANSSEN PRODS Labeling Approval
12/22/2020 IMBRUVICA
NDA #210563		 SUPPL-10 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
12/22/2020 AMBRISENTAN
ANDA #210715		 SUPPL-4 AMBRISENTAN CIPLA REMS Approval
12/22/2020 AMBRISENTAN
ANDA #210784		 SUPPL-4 AMBRISENTAN SUN PHARM REMS Approval
12/23/2020 FURADANTIN
NDA #009175		 SUPPL-48 NITROFURANTOIN CASPER PHARMA LLC Labeling Approval
12/23/2020 ANTIZOL
NDA #020696		 SUPPL-6 FOMEPIZOLE PAR PHARM INC Labeling Approval
12/23/2020 ACTIQ
NDA #020747		 SUPPL-50 FENTANYL CITRATE CEPHALON REMS Approval
12/23/2020 ZOVIRAX
NDA #021478		 SUPPL-10 ACYCLOVIR BAUSCH Labeling Approval
12/23/2020 FENTORA
NDA #021947		 SUPPL-30 FENTANYL CITRATE CEPHALON REMS Approval
12/23/2020 ONSOLIS
NDA #022266		 SUPPL-24 FENTANYL CITRATE ADALVO REMS Approval
12/23/2020 LAZANDA
NDA #022569		 SUPPL-29 FENTANYL CITRATE BTCP PHARMA REMS Approval
12/23/2020 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-43 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
12/23/2020 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-46 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
12/23/2020 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-48 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
12/23/2020 VINORELBINE TARTRATE
ANDA #076028		 SUPPL-24 VINORELBINE TARTRATE TEVA PHARMS USA Labeling Approval
12/23/2020 FOMEPIZOLE
ANDA #078368		 SUPPL-9 FOMEPIZOLE AM REGENT Labeling Approval
12/23/2020 FOMEPIZOLE
ANDA #078537		 SUPPL-8 FOMEPIZOLE NAVINTA LLC Labeling Approval
12/23/2020 FOMEPIZOLE
ANDA #078639		 SUPPL-4 FOMEPIZOLE MYLAN INSTITUTIONAL Labeling Approval
12/23/2020 FOSPHENYTOIN SODIUM
ANDA #078736		 SUPPL-10 FOSPHENYTOIN SODIUM NORVIUM BIOSCIENCE Labeling Approval
12/23/2020 FENTANYL CITRATE
ANDA #078907		 SUPPL-17 FENTANYL CITRATE SPECGX LLC REMS Approval
12/23/2020 FENTANYL CITRATE
ANDA #079075		 SUPPL-14 FENTANYL CITRATE WATSON LABS REMS Approval
12/23/2020 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-26 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
12/23/2020 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-30 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
12/23/2020 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-33 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
12/23/2020 APREPITANT
ANDA #090999		 SUPPL-12 APREPITANT SANDOZ Labeling Approval
12/23/2020 APREPITANT
ANDA #090999		 SUPPL-14 APREPITANT SANDOZ Labeling Approval
12/23/2020 ACYCLOVIR
ANDA #202168		 SUPPL-2 ACYCLOVIR CADILA PHARMS LTD Labeling Approval
12/23/2020 SUBSYS
NDA #202788		 SUPPL-21 FENTANYL BTCP PHARMA REMS Approval
12/23/2020 TACROLIMUS
ANDA #206651		 SUPPL-1 TACROLIMUS BELCHER Labeling Approval
12/23/2020 FLUOXETINE HYDROCHLORIDE
ANDA #206993		 SUPPL-2 FLUOXETINE HYDROCHLORIDE CADILA PHARMS LTD Labeling Approval
12/23/2020 FENTANYL CITRATE
ANDA #207338		 SUPPL-1 FENTANYL CITRATE ACTAVIS LABS FL INC REMS Approval
12/23/2020 FENOFIBRIC ACID
ANDA #212562		 ORIG-1 CHOLINE FENOFIBRATE YICHANG HUMANWELL Approval
12/23/2020 GEMTESA
NDA #213006		 ORIG-1 VIBEGRON UROVANT Type 1 - New Molecular Entity Approval
12/23/2020 MEPSEVII
BLA #761047		 SUPPL-5 VESTRONIDASE ALFA-VJBK ULTRAGENYX PHARM INC Approval
12/24/2020 EPI E Z PEN JR
NDA #019430		 SUPPL-91 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
12/24/2020 EPIPEN
NDA #019430		 SUPPL-91 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
12/24/2020 EPIPEN E Z PEN
NDA #019430		 SUPPL-91 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
12/24/2020 EPIPEN JR.
NDA #019430		 SUPPL-91 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
12/28/2020 IFOSFAMIDE
ANDA #076619		 SUPPL-7 IFOSFAMIDE HIKMA Labeling Approval
12/28/2020 KALBITOR
BLA #125277		 SUPPL-81 ECALLANTIDE DYAX CORP. Approval
12/28/2020 RADIOGENIX SYSTEM
NDA #202158		 SUPPL-15 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR NORTHSTAR MEDICAL Manufacturing (CMC) Approval
12/28/2020 SEVELAMER CARBONATE
ANDA #203860		 SUPPL-9 SEVELAMER CARBONATE INVAGEN PHARMS Labeling Approval
12/28/2020 MILNACIPRAN HYDROCHLORIDE
ANDA #205367		 ORIG-1 MILNACIPRAN HYDROCHLORIDE MYLAN PHARMS INC Tentative Approval
12/28/2020 NEBIVOLOL HYDROCHLORIDE
ANDA #206729		 ORIG-1 NEBIVOLOL HYDROCHLORIDE MICRO LABS LTD Tentative Approval
12/28/2020 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #206906		 SUPPL-4 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL AUROBINDO PHARMA Labeling Approval
12/28/2020 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #207073		 SUPPL-12 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL ALEMBIC Labeling Approval
12/28/2020 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #207435		 SUPPL-3 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL MICRO LABS Labeling Approval
12/28/2020 GLUCAGON
ANDA #208086		 ORIG-1 GLUCAGON AMPHASTAR PHARMS INC Approval
12/28/2020 LURASIDONE HYDROCHLORIDE
ANDA #212091		 ORIG-1 LURASIDONE HYDROCHLORIDE SLATE RUN PHARMA Approval
12/29/2020 PURINETHOL
NDA #009053		 SUPPL-40 MERCAPTOPURINE STASON PHARMS Labeling Approval
12/29/2020 MEN'S ROGAINE
NDA #021812		 SUPPL-16 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
12/29/2020 WOMEN'S ROGAINE
NDA #021812		 SUPPL-16 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
12/29/2020 JALYN
NDA #022460		 SUPPL-11 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE WAYLIS THERAP Labeling Approval
12/29/2020 BENZPHETAMINE HYDROCHLORIDE
ANDA #040845		 SUPPL-4 BENZPHETAMINE HYDROCHLORIDE IMPAX LABS Labeling Approval
12/29/2020 OPDIVO
BLA #125554		 SUPPL-95 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
12/29/2020 TADALAFIL
ANDA #210716		 ORIG-1 TADALAFIL CHARTWELL RX Approval
12/29/2020 EMPAGLIFLOZIN
ANDA #212322		 ORIG-1 EMPAGLIFLOZIN AIZANT Tentative Approval
12/29/2020 GABAPENTIN ENCARBIL
ANDA #213501		 ORIG-1 GABAPENTIN ENCARBIL GLENMARK PHARMS LTD Tentative Approval
12/29/2020 POTASSIUM CHLORIDE
ANDA #214422		 ORIG-1 POTASSIUM CHLORIDE ASCENT PHARMS INC Approval
12/29/2020 HEPARIN SODIUM
ANDA #214804		 ORIG-1 HEPARIN SODIUM BE PHARMS Approval
12/29/2020 HEPARIN SODIUM
ANDA #214839		 ORIG-1 HEPARIN SODIUM BE PHARMS Approval
12/30/2020 PROGRAF
NDA #050708		 SUPPL-52 TACROLIMUS ASTELLAS Labeling Approval
12/30/2020 PROGRAF
NDA #050709		 SUPPL-44 TACROLIMUS ASTELLAS Labeling Approval
12/30/2020 ASTAGRAF XL
NDA #204096		 SUPPL-9 TACROLIMUS ASTELLAS Labeling Approval
12/30/2020 DULOXETINE HYDROCHLORIDE
ANDA #204343		 SUPPL-3 DULOXETINE HYDROCHLORIDE HETERO LABS LTD III Labeling Approval
12/30/2020 DULOXETINE HYDROCHLORIDE
ANDA #204343		 SUPPL-4 DULOXETINE HYDROCHLORIDE HETERO LABS LTD III Manufacturing (CMC) Approval
12/30/2020 DULOXETINE HYDROCHLORIDE
ANDA #204343		 SUPPL-7 DULOXETINE HYDROCHLORIDE HETERO LABS LTD III Labeling Approval
12/30/2020 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206908		 ORIG-1 LEVOFLOXACIN GLAND PHARMA LTD Approval
12/30/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #208004		 ORIG-1 FINGOLIMOD HYDROCHLORIDE ALKEM LABS LTD Approval
12/30/2020 PROGRAF
NDA #210115		 SUPPL-4 TACROLIMUS ASTELLAS Labeling Approval
12/31/2020 ALEVE
NDA #020204		 SUPPL-77 NAPROXEN SODIUM BAYER Labeling Approval
12/31/2020 ALEVE
NDA #020204		 SUPPL-78 NAPROXEN SODIUM BAYER Labeling Approval
12/31/2020 ALEVE
NDA #020204		 SUPPL-79 NAPROXEN SODIUM BAYER Labeling Approval
12/31/2020 ALEVE
NDA #020204		 SUPPL-80 NAPROXEN SODIUM BAYER Labeling Approval
12/31/2020 GONAL-F
BLA #020378		 SUPPL-45 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F
BLA #020378		 SUPPL-67 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F
BLA #020378		 SUPPL-75 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 PEXEVA
NDA #021299		 SUPPL-31 PAROXETINE MESYLATE SEBELA IRELAND LTD Labeling Approval
12/31/2020 GONAL-F
BLA #021765		 SUPPL-13 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F
BLA #021765		 SUPPL-14 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F
BLA #021765		 SUPPL-44 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F RFF
BLA #021765		 SUPPL-13 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F RFF
BLA #021765		 SUPPL-14 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 GONAL-F RFF
BLA #021765		 SUPPL-44 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/31/2020 PIMTREA
ANDA #091247		 SUPPL-8 DESOGESTREL; ETHINYL ESTRADIOL NOVAST LABS Labeling Approval
12/31/2020 XULANE
ANDA #200910		 SUPPL-10 ETHINYL ESTRADIOL; NORELGESTROMIN MYLAN TECHNOLOGIES Labeling Approval
12/31/2020 BUPROPION HYDROCHLORIDE
ANDA #203650		 ORIG-1 BUPROPION HYDROCHLORIDE SUN PHARM Approval
12/31/2020 OLANZAPINE
ANDA #206892		 ORIG-1 OLANZAPINE HISUN PHARM HANGZHOU Approval
12/31/2020 OLANZAPINE
ANDA #206924		 ORIG-1 OLANZAPINE HISUN PHARM HANGZHOU Approval
12/31/2020 CLINDAMYCIN PHOSPHATE
ANDA #212104		 ORIG-1 CLINDAMYCIN PHOSPHATE PADAGIS ISRAEL Approval
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