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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 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 April 24, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/01/2021 SINE-AID IB
NDA #019899		 SUPPL-20 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
12/01/2021 CARBATROL
NDA #020712		 SUPPL-37 CARBAMAZEPINE TAKEDA PHARMS USA Labeling Approval
12/01/2021 EOVIST
NDA #022090		 SUPPL-19 GADOXETATE DISODIUM BAYER HLTHCARE Labeling Approval
12/01/2021 ARIPIPRAZOLE
ANDA #203025		 ORIG-1 ARIPIPRAZOLE UNICHEM Approval
12/01/2021 ABIRATERONE ACETATE
ANDA #208416		 SUPPL-7 ABIRATERONE ACETATE DR REDDYS Labeling Approval
12/01/2021 ATROPINE SULFATE
ANDA #213561		 ORIG-1 ATROPINE SULFATE HIKMA Approval
12/01/2021 METHYLPHENIDATE HYDROCHLORIDE
ANDA #215688		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ASCENT PHARMS INC Tentative Approval
12/02/2021 CEREBYX
NDA #020450		 SUPPL-45 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
12/02/2021 RITUXAN
BLA #103705		 SUPPL-5465 RITUXIMAB GENENTECH Approval
12/02/2021 TEFLARO
NDA #200327		 SUPPL-28 CEFTAROLINE FOSAMIL ABBVIE Labeling Approval
12/02/2021 XELJANZ
NDA #203214		 SUPPL-31 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
12/02/2021 CINACALCET HYDROCHLORIDE
ANDA #204364		 ORIG-1 CINACALCET HYDROCHLORIDE STEVENS J Approval
12/02/2021 GLYCEROL PHENYLBUTYRATE
ANDA #205742		 ORIG-1 GLYCEROL PHENYLBUTYRATE PAR PHARM INC Approval
12/02/2021 OLUMIANT
NDA #207924		 SUPPL-4 BARICITINIB ELI LILLY AND CO Labeling Approval
12/02/2021 XELJANZ XR
NDA #208246		 SUPPL-17 TOFACITINIB CITRATE PFIZER Labeling Approval
12/02/2021 RINVOQ
NDA #211675		 SUPPL-8 UPADACITINIB ABBVIE Labeling Approval
12/02/2021 XELJANZ
NDA #213082		 SUPPL-4 TOFACITINIB CITRATE PFIZER Labeling Approval
12/02/2021 ARSENIC TRIOXIDE
ANDA #215359		 ORIG-1 ARSENIC TRIOXIDE SANDOZ Approval
12/03/2021 ACTIQ
NDA #020747		 SUPPL-55 FENTANYL CITRATE CEPHALON REMS Approval
12/03/2021 FENTORA
NDA #021947		 SUPPL-37 FENTANYL CITRATE CEPHALON REMS Approval
12/03/2021 ONSOLIS
NDA #022266		 SUPPL-26 FENTANYL CITRATE ADALVO REMS Approval
12/03/2021 LAZANDA
NDA #022569		 SUPPL-31 FENTANYL CITRATE BTCP PHARMA REMS Approval
12/03/2021 DORZOLAMIDE HYDROCHLORIDE
ANDA #077846		 SUPPL-11 DORZOLAMIDE HYDROCHLORIDE HIKMA Labeling Approval
12/03/2021 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #077847		 SUPPL-12 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE HIKMA Labeling Approval
12/03/2021 DORZOLAMIDE HYDROCHLORIDE
ANDA #078395		 SUPPL-10 DORZOLAMIDE HYDROCHLORIDE RUBICON Labeling Approval
12/03/2021 FENTANYL CITRATE
ANDA #078907		 SUPPL-22 FENTANYL CITRATE SPECGX LLC REMS Approval
12/03/2021 FENTANYL CITRATE
ANDA #079075		 SUPPL-15 FENTANYL CITRATE WATSON LABS REMS Approval
12/03/2021 IRBESARTAN
ANDA #090201		 SUPPL-8 IRBESARTAN HIKMA Labeling Approval
12/03/2021 LOSARTAN POTASSIUM
ANDA #090382		 SUPPL-16 LOSARTAN POTASSIUM STRIDES PHARMA Labeling Approval
12/03/2021 LOSARTAN POTASSIUM
ANDA #090382		 SUPPL-27 LOSARTAN POTASSIUM STRIDES PHARMA Labeling Approval
12/03/2021 KEYTRUDA
BLA #125514		 SUPPL-112 PEMBROLIZUMAB MERCK SHARP DOHME Approval
12/03/2021 IRBESARTAN
ANDA #201531		 SUPPL-12 IRBESARTAN LUPIN LTD Labeling Approval
12/03/2021 SUBSYS
NDA #202788		 SUPPL-28 FENTANYL BTCP PHARMA REMS Approval
12/03/2021 TAFINLAR
NDA #202806		 SUPPL-20 DABRAFENIB MESYLATE NOVARTIS Labeling Approval
12/03/2021 MEKINIST
NDA #204114		 SUPPL-20 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Labeling Approval
12/03/2021 PROVAYBLUE
NDA #204630		 SUPPL-8 METHYLENE BLUE PROVEPHARM SAS Manufacturing (CMC) Approval
12/03/2021 FENTANYL CITRATE
ANDA #207338		 SUPPL-2 FENTANYL CITRATE ACTAVIS LABS FL INC REMS Approval
12/03/2021 CLOBAZAM
ANDA #210039		 SUPPL-3 CLOBAZAM AMNEAL Labeling Approval
12/03/2021 CLOBAZAM
ANDA #210545		 SUPPL-1 CLOBAZAM LUPIN LTD Labeling Approval
12/03/2021 CLOBAZAM
ANDA #210546		 SUPPL-2 CLOBAZAM LUPIN LTD Labeling Approval
12/03/2021 CLOBAZAM
ANDA #210569		 SUPPL-3 CLOBAZAM UPSHER SMITH LABS Labeling Approval
12/03/2021 VORTIOXETINE HYDROBROMIDE
ANDA #211101		 ORIG-1 VORTIOXETINE HYDROBROMIDE MSN LABORATORIES PRIVATE LTD Tentative Approval
12/03/2021 SUCCINYLCHOLINE CHLORIDE
ANDA #211589		 SUPPL-1 SUCCINYLCHOLINE CHLORIDE SOMERSET THERAPS LLC Labeling Approval
12/03/2021 SOLIFENACIN SUCCINATE
ANDA #211657		 SUPPL-5 SOLIFENACIN SUCCINATE SCIEGEN PHARMS INC Labeling Approval
12/03/2021 INREBIC
NDA #212327		 SUPPL-3 FEDRATINIB HYDROCHLORIDE BRISTOL-MYERS Labeling Approval
12/03/2021 METFORMIN HYDROCHLORIDE
ANDA #213320		 ORIG-1 METFORMIN HYDROCHLORIDE HARMAN FINOCHEM Approval
12/04/2021 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-86 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
12/04/2021 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-43 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
12/06/2021 SUNITINIB MALATE
ANDA #201275		 ORIG-1 SUNITINIB MALATE MYLAN Approval
12/06/2021 VALSARTAN
ANDA #202223		 SUPPL-14 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
12/06/2021 VALSARTAN
ANDA #202223		 SUPPL-15 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
12/06/2021 VALSARTAN
ANDA #202223		 SUPPL-16 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
12/06/2021 VALSARTAN
ANDA #202696		 SUPPL-23 VALSARTAN MACLEODS PHARMS LTD Labeling Approval
12/06/2021 MESALAMINE
ANDA #203817		 SUPPL-7 MESALAMINE ACTAVIS LABS FL Labeling Approval
12/06/2021 MESALAMINE
ANDA #203817		 SUPPL-8 MESALAMINE ACTAVIS LABS FL Labeling Approval
12/06/2021 NUVESSA
NDA #205223		 SUPPL-5 METRONIDAZOLE CHEMO RESEARCH SL Labeling Approval
12/07/2021 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-40 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Manufacturing (CMC) Approval
12/07/2021 VALSARTAN
ANDA #203311		 SUPPL-15 VALSARTAN HETERO LABS LTD V Labeling Approval
12/07/2021 VALSARTAN
ANDA #203311		 SUPPL-16 VALSARTAN HETERO LABS LTD V Labeling Approval
12/07/2021 SIKLOS
NDA #208843		 SUPPL-3 HYDROXYUREA THERAVIA Efficacy Approval
12/07/2021 FEBUXOSTAT
ANDA #212924		 ORIG-1 FEBUXOSTAT ALKEM LABS LTD Approval
12/07/2021 CANGRELOR
ANDA #213551		 ORIG-1 CANGRELOR GLAND PHARMA LTD Tentative Approval
12/07/2021 XACIATO
NDA #215650		 ORIG-1 CLINDAMYCIN PHOSPHATE ORGANON LLC Type 5 - New Formulation or New Manufacturer Approval
12/07/2021 EBANGA
BLA #761172		 SUPPL-2 ANSUVIMAB-ZYKL RIDGEBACK BIOTHERAPEUTICS Approval
12/08/2021 PIPERACILLIN AND TAZOBACTAM
ANDA #065362		 SUPPL-33 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
12/08/2021 MEDROXYPROGESTERONE ACETATE
ANDA #076553		 SUPPL-22 MEDROXYPROGESTERONE ACETATE HONG KONG Labeling Approval
12/08/2021 MEDROXYPROGESTERONE ACETATE
ANDA #076553		 SUPPL-23 MEDROXYPROGESTERONE ACETATE HONG KONG Labeling Approval
12/08/2021 MEDROXYPROGESTERONE ACETATE
ANDA #076553		 SUPPL-30 MEDROXYPROGESTERONE ACETATE HONG KONG Labeling Approval
12/08/2021 MEDROXYPROGESTERONE ACETATE
ANDA #076553		 SUPPL-31 MEDROXYPROGESTERONE ACETATE HONG KONG Labeling Approval
12/08/2021 IRBESARTAN
ANDA #091236		 SUPPL-16 IRBESARTAN ALEMBIC PHARMS LTD Labeling Approval
12/08/2021 IRBESARTAN
ANDA #091236		 SUPPL-20 IRBESARTAN ALEMBIC PHARMS LTD Labeling Approval
12/08/2021 IRBESARTAN
ANDA #202254		 SUPPL-37 IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
12/08/2021 IRBESARTAN
ANDA #202254		 SUPPL-41 IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
12/08/2021 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 SUPPL-24 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
12/08/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #207018		 SUPPL-4 HYDROCHLOROTHIAZIDE; IRBESARTAN UNICHEM Labeling Approval
12/08/2021 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #207018		 SUPPL-6 HYDROCHLOROTHIAZIDE; IRBESARTAN UNICHEM Labeling Approval
12/08/2021 ROMIDEPSIN
NDA #208574		 SUPPL-6 ROMIDEPSIN TEVA PHARMS USA INC Labeling Approval
12/08/2021 THIOTEPA
ANDA #211831		 ORIG-1 THIOTEPA BELOTECA Approval
12/08/2021 ZYNRELEF KIT
NDA #211988		 SUPPL-5 BUPIVACAINE; MELOXICAM HERON THERAPS INC Efficacy Approval
12/08/2021 NURTEC ODT
NDA #212728		 SUPPL-12 RIMEGEPANT SULFATE PFIZER Labeling Approval
12/08/2021 LAMOTRIGINE
ANDA #213949		 ORIG-1 LAMOTRIGINE YILING Approval
12/08/2021 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #215523		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE ASCENT PHARMS INC Approval
12/09/2021 XYREM
NDA #021196		 SUPPL-38 SODIUM OXYBATE JAZZ PHARMS REMS Approval
12/09/2021 CRESEMBA
NDA #207500		 SUPPL-10 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
12/09/2021 CRESEMBA
NDA #207501		 SUPPL-8 ISAVUCONAZONIUM SULFATE ASTELLAS Labeling Approval
12/09/2021 VERARING
ANDA #207577		 ORIG-1 ETHINYL ESTRADIOL; ETONOGESTREL DR REDDYS LABS SA Approval
12/09/2021 ZEPATIER
NDA #208261		 SUPPL-7 ELBASVIR; GRAZOPREVIR MSD SUB MERCK Efficacy Approval
12/09/2021 XYWAV
NDA #212690		 SUPPL-8 CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE JAZZ REMS Approval
12/09/2021 ENTADFI
NDA #215423		 ORIG-1 FINASTERIDE; TADALAFIL BLUE WATER BIOTECH Type 4 - New Combination Approval
12/10/2021 MAXIDEX
NDA #013422		 SUPPL-49 DEXAMETHASONE HARROW EYE Labeling Approval
12/10/2021 UROCIT-K
NDA #019071		 SUPPL-13 POTASSIUM CITRATE MISSION PHARMA Labeling Approval
12/10/2021 EPZICOM
NDA #021652		 SUPPL-29 ABACAVIR SULFATE; LAMIVUDINE VIIV HLTHCARE Efficacy Approval
12/10/2021 LASTACAFT
NDA #022134		 SUPPL-8 ALCAFTADINE ABBVIE Efficacy Approval
12/10/2021 TYSABRI
BLA #125104		 SUPPL-973 NATALIZUMAB BIOGEN IDEC Approval
12/10/2021 TYSABRI
BLA #125104		 SUPPL-975 NATALIZUMAB BIOGEN IDEC Approval
12/10/2021 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-10 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
12/10/2021 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-16 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
12/10/2021 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-22 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
12/10/2021 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-27 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
12/10/2021 ESCITALOPRAM OXALATE
ANDA #202227		 SUPPL-14 ESCITALOPRAM OXALATE AMNEAL PHARMS Labeling Approval
12/10/2021 GEMFIBROZIL
ANDA #202726		 SUPPL-10 GEMFIBROZIL AUROBINDO PHARMA LTD Labeling Approval
12/10/2021 GEMFIBROZIL
ANDA #203266		 SUPPL-5 GEMFIBROZIL CADILA PHARMS LTD Labeling Approval
12/10/2021 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #204169		 SUPPL-18 HYDROCHLOROTHIAZIDE; TELMISARTAN MACLEODS PHARMS LTD Labeling Approval
12/10/2021 GEMFIBROZIL
ANDA #204189		 SUPPL-1 GEMFIBROZIL CADILA Labeling Approval
12/10/2021 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #204221		 SUPPL-2 HYDROCHLOROTHIAZIDE; TELMISARTAN ZYDUS PHARMS Labeling Approval
12/10/2021 GALAFOLD
NDA #208623		 SUPPL-5 MIGALASTAT HYDROCHLORIDE AMICUS THERAP US Labeling Approval
12/10/2021 KISQALI
NDA #209092		 SUPPL-8 RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
12/10/2021 KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935		 SUPPL-14 LETROZOLE; RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
12/13/2021 LIORESAL
NDA #020075		 SUPPL-38 BACLOFEN AMNEAL Manufacturing (CMC) Approval
12/13/2021 THYRO-TABS
NDA #021116		 SUPPL-21 LEVOTHYROXINE SODIUM ALVOGEN Efficacy Approval
12/13/2021 NAPROXEN SODIUM
NDA #021920		 SUPPL-36 NAPROXEN SODIUM BIONPHARMA Labeling Approval
12/13/2021 VOTRIENT
NDA #022465		 SUPPL-33 PAZOPANIB HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
12/13/2021 LOPERAMIDE HYDROCHLORIDE
ANDA #091292		 SUPPL-12 LOPERAMIDE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
12/13/2021 LOPERAMIDE HYDROCHLORIDE
ANDA #091292		 SUPPL-16 LOPERAMIDE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
12/13/2021 BUPROPION HYDROCHLORIDE
ANDA #206122		 SUPPL-3 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
12/13/2021 BUPROPION HYDROCHLORIDE
ANDA #206122		 SUPPL-5 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
12/13/2021 BUPROPION HYDROCHLORIDE
ANDA #206122		 SUPPL-7 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Manufacturing (CMC) Approval
12/13/2021 TIMOLOL MALEATE
ANDA #212592		 ORIG-1 TIMOLOL MALEATE AMRING PHARMS Approval
12/13/2021 METFORMIN HYDROCHLORIDE
ANDA #213356		 ORIG-1 METFORMIN HYDROCHLORIDE APOTEX Approval
12/13/2021 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
ANDA #213948		 ORIG-1 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE TEVA PHARMS USA Approval
12/14/2021 CORTROSYN
NDA #016750		 SUPPL-32 COSYNTROPIN AMPHASTAR PHARMS INC Labeling Approval
12/14/2021 ADVIL
NDA #018989		 SUPPL-99 IBUPROFEN HALEON US HOLDINGS Labeling Approval
12/14/2021 CHILDREN'S ZYRTEC ALLERGY
NDA #021621		 SUPPL-12 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
12/14/2021 CHILDREN'S ZYRTEC HIVES RELIEF
NDA #021621		 SUPPL-12 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
12/14/2021 XELJANZ
NDA #203214		 SUPPL-28 TOFACITINIB CITRATE PF PRISM CV Efficacy Approval
12/14/2021 XELJANZ XR
NDA #208246		 SUPPL-13 TOFACITINIB CITRATE PFIZER Efficacy Approval
12/14/2021 RINVOQ
NDA #211675		 SUPPL-2 UPADACITINIB ABBVIE Efficacy Approval
12/14/2021 RINVOQ
NDA #211675		 SUPPL-5 UPADACITINIB ABBVIE Labeling Approval
12/14/2021 AMPHOTERICIN B
ANDA #212514		 ORIG-1 AMPHOTERICIN B SPIL Approval
12/14/2021 XELJANZ
NDA #213082		 SUPPL-3 TOFACITINIB CITRATE PFIZER Labeling Approval
12/14/2021 CELECOXIB
ANDA #213301		 SUPPL-2 CELECOXIB UNICHEM Labeling Approval
12/15/2021 FLAGYL
NDA #012623		 SUPPL-69 METRONIDAZOLE PFIZER Labeling Approval
12/15/2021 METRONIDAZOLE
NDA #018620		 SUPPL-23 METRONIDAZOLE FOSUN PHARMA Labeling Approval
12/15/2021 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018657		 SUPPL-39 METRONIDAZOLE BAXTER HLTHCARE Labeling Approval
12/15/2021 METRONIDAZOLE
NDA #018740		 SUPPL-41 METRONIDAZOLE FOSUN PHARMA Labeling Approval
12/15/2021 METRONIDAZOLE
NDA #018764		 SUPPL-44 METRONIDAZOLE WATSON LABS Labeling Approval
12/15/2021 METRONIDAZOLE
NDA #018845		 SUPPL-16 METRONIDAZOLE CHARTWELL MOLECULES Labeling Approval
12/15/2021 METRONIDAZOLE IN PLASTIC CONTAINER
NDA #018890		 SUPPL-54 METRONIDAZOLE HOSPIRA Labeling Approval
12/15/2021 METRO I.V. IN PLASTIC CONTAINER
NDA #018900		 SUPPL-41 METRONIDAZOLE B BRAUN Labeling Approval
12/15/2021 METRONIDAZOLE
NDA #018907		 SUPPL-7 METRONIDAZOLE HIKMA Labeling Approval
12/15/2021 METRONIDAZOLE
NDA #018930		 SUPPL-15 METRONIDAZOLE CHARTWELL MOLECULES Labeling Approval
12/15/2021 FLAGYL
NDA #020334		 SUPPL-12 METRONIDAZOLE PFIZER Labeling Approval
12/15/2021 FLAGYL ER
NDA #020868		 SUPPL-14 METRONIDAZOLE PFIZER Labeling Approval
12/15/2021 TINDAMAX
NDA #021618		 SUPPL-8 TINIDAZOLE MISSION PHARMA Labeling Approval
12/15/2021 HELIDAC
NDA #050719		 SUPPL-24 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE CASPER PHARMA LLC Labeling Approval
12/15/2021 PYLERA
NDA #050786		 SUPPL-25 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Labeling Approval
12/15/2021 ORACEA
NDA #050805		 SUPPL-11 DOXYCYCLINE GALDERMA LABS LP Labeling Approval
12/15/2021 METRONIDAZOLE
ANDA #090222		 SUPPL-3 METRONIDAZOLE ALEMBIC Labeling Approval
12/15/2021 ORENCIA
BLA #125118		 SUPPL-240 ABATACEPT BRISTOL MYERS SQUIBB Approval
12/15/2021 MORPHINE SULFATE
ANDA #202104		 SUPPL-13 MORPHINE SULFATE UPSHER SMITH LABS Labeling Approval
12/15/2021 MORPHINE SULFATE
ANDA #202104		 SUPPL-14 MORPHINE SULFATE UPSHER SMITH LABS Labeling Approval
12/15/2021 MORPHINE SULFATE
ANDA #202104		 SUPPL-18 MORPHINE SULFATE UPSHER SMITH LABS Labeling Approval
12/15/2021 BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
ANDA #202584		 SUPPL-2 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE NOSTRUM LABS INC Labeling Approval
12/15/2021 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204079		 SUPPL-12 MOXIFLOXACIN HYDROCHLORIDE LUPIN LTD Labeling Approval
12/15/2021 OXALIPLATIN
ANDA #207325		 SUPPL-4 OXALIPLATIN GLAND Labeling Approval
12/15/2021 SOLOSEC
NDA #209363		 SUPPL-17 SECNIDAZOLE LUPIN Labeling Approval
12/15/2021 BENZNIDAZOLE
NDA #209570		 SUPPL-2 BENZNIDAZOLE CHEMO RESEARCH SL Labeling Approval
12/15/2021 ZEPOSIA
NDA #209899		 SUPPL-3 OZANIMOD HYDROCHLORIDE BRISTOL Labeling Approval
12/15/2021 VASOPRESSIN
ANDA #211538		 ORIG-1 VASOPRESSIN EAGLE PHARMS Approval
12/15/2021 FEXINIDAZOLE
NDA #214429		 SUPPL-1 FEXINIDAZOLE SANOFI Labeling Approval
12/15/2021 TARPEYO
NDA #215935		 ORIG-1 BUDESONIDE CALLIDITAS Type 5 - New Formulation or New Manufacturer Approval
12/16/2021 ALINIA
NDA #021497		 SUPPL-17 NITAZOXANIDE ROMARK Labeling Approval
12/16/2021 OSELTAMIVIR PHOSPHATE
ANDA #208823		 SUPPL-2 OSELTAMIVIR PHOSPHATE ALVOGEN Labeling Approval
12/16/2021 OSELTAMIVIR PHOSPHATE
ANDA #208823		 SUPPL-5 OSELTAMIVIR PHOSPHATE ALVOGEN Labeling Approval
12/16/2021 OSELTAMIVIR PHOSPHATE
ANDA #208823		 SUPPL-7 OSELTAMIVIR PHOSPHATE ALVOGEN Labeling Approval
12/16/2021 OSELTAMIVIR PHOSPHATE
ANDA #211823		 SUPPL-1 OSELTAMIVIR PHOSPHATE ALEMBIC Labeling Approval
12/16/2021 DARTISLA ODT
NDA #215019		 ORIG-1 GLYCOPYRROLATE EDENBRIDGE PHARMS Type 3 - New Dosage Form Approval
12/16/2021 HEMLIBRA
BLA #761083		 SUPPL-13 EMICIZUMAB GENENTECH INC Approval
12/17/2021 LEVOLET
NDA #021137		 SUPPL-2 LEVOTHYROXINE SODIUM GENUS LIFESCIENCES Efficacy Approval
12/17/2021 LEVOLET
NDA #021137		 SUPPL-3 LEVOTHYROXINE SODIUM GENUS LIFESCIENCES Efficacy Approval
12/17/2021 LEVOLET
NDA #021137		 SUPPL-4 LEVOTHYROXINE SODIUM GENUS LIFESCIENCES Efficacy Approval
12/17/2021 LOSARTAN POTASSIUM
ANDA #090428		 SUPPL-14 LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
12/17/2021 LOSARTAN POTASSIUM
ANDA #090428		 SUPPL-28 LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
12/17/2021 RITUXAN
BLA #103705		 SUPPL-5467 RITUXIMAB GENENTECH Approval
12/17/2021 KEYTRUDA
BLA #125514		 SUPPL-120 PEMBROLIZUMAB MERCK SHARP DOHME Approval
12/17/2021 VORICONAZOLE
NDA #208562		 SUPPL-4 VORICONAZOLE XELLIA PHARMS APS Labeling Approval
12/17/2021 NEBIVOLOL HYDROCHLORIDE
ANDA #208717		 ORIG-1 NEBIVOLOL HYDROCHLORIDE CADILA PHARMS LTD Approval
12/17/2021 CAPLYTA
NDA #209500		 SUPPL-5 LUMATEPERONE TOSYLATE INTRA-CELLULAR Efficacy Approval
12/17/2021 CAPLYTA
NDA #209500		 SUPPL-6 LUMATEPERONE TOSYLATE INTRA-CELLULAR Efficacy Approval
12/17/2021 NEBIVOLOL HYDROCHLORIDE
ANDA #211053		 ORIG-1 NEBIVOLOL HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
12/17/2021 COPIKTRA
NDA #211155		 SUPPL-5 DUVELISIB SECURA Labeling Approval
12/17/2021 NEBIVOLOL HYDROCHLORIDE
ANDA #212917		 ORIG-1 NEBIVOLOL HYDROCHLORIDE REYOUNG Approval
12/17/2021 OXBRYTA
NDA #213137		 SUPPL-6 VOXELOTOR GLOBAL BLOOD THERAPS Efficacy Approval
12/17/2021 ELUXADOLINE
ANDA #213613		 ORIG-1 ELUXADOLINE ASCEND LABORATORIES, LTD Tentative Approval
12/17/2021 ILLUCCIX
NDA #214032		 ORIG-1 GALLIUM GA-68 GOZETOTIDE TELIX Type 3 - New Dosage Form and Type 4 - New Combination Approval
12/17/2021 RIFABUTIN
ANDA #215041		 ORIG-1 RIFABUTIN NOVITIUM PHARMA Approval
12/17/2021 LANREOTIDE ACETATE
NDA #215395		 ORIG-1 LANREOTIDE ACETATE INVAGEN PHARMS Type 5 - New Formulation or New Manufacturer Approval
12/17/2021 OXBRYTA
NDA #216157		 ORIG-1 VOXELOTOR GLOBAL BLOOD THERAPS Type 3 - New Dosage Form Approval
12/17/2021 VYVGART
BLA #761195		 ORIG-1 EFGARTIGIMOD ALFA ARGENX BV Approval
12/17/2021 REZVOGLAR
BLA #761215		 ORIG-1 INSULIN GLARGINE-AGLR ELI LILLY CO Approval
12/17/2021 YUSIMRY
BLA #761216		 ORIG-1 ADALIMUMAB-AQVH COHERUS BIOSCIENCES INC Approval
12/17/2021 TEZSPIRE
BLA #761224		 ORIG-1 TEZEPELUMAB-EKKO ASTRAZENECA AB Approval
12/19/2021 LENVIMA
NDA #206947		 SUPPL-21 LENVATINIB MESYLATE EISAI INC Efficacy Approval
12/20/2021 IMITREX
NDA #020080		 SUPPL-54 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
12/20/2021 IMITREX STATDOSE
NDA #020080		 SUPPL-54 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
12/20/2021 LOVENOX
NDA #020164		 SUPPL-129 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
12/20/2021 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-129 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
12/20/2021 VERAPAMIL HYDROCHLORIDE
ANDA #070737		 SUPPL-25 VERAPAMIL HYDROCHLORIDE HOSPIRA Labeling Approval
12/20/2021 VERAPAMIL HYDROCHLORIDE
ANDA #070738		 SUPPL-16 VERAPAMIL HYDROCHLORIDE HOSPIRA Labeling Approval
12/20/2021 VERAPAMIL HYDROCHLORIDE
ANDA #070738		 SUPPL-17 VERAPAMIL HYDROCHLORIDE HOSPIRA Labeling Approval
12/20/2021 VERAPAMIL HYDROCHLORIDE
ANDA #075136		 SUPPL-12 VERAPAMIL HYDROCHLORIDE HOSPIRA Labeling Approval
12/20/2021 VERAPAMIL HYDROCHLORIDE
ANDA #075136		 SUPPL-14 VERAPAMIL HYDROCHLORIDE HOSPIRA Labeling Approval
12/20/2021 IRBESARTAN
ANDA #203020		 SUPPL-3 IRBESARTAN UNICHEM Labeling Approval
12/20/2021 IRBESARTAN
ANDA #203081		 SUPPL-19 IRBESARTAN AUROBINDO PHARMA LTD Labeling Approval
12/20/2021 OTEZLA
NDA #205437		 SUPPL-11 APREMILAST AMGEN INC Efficacy Approval
12/20/2021 ABIRATERONE ACETATE
ANDA #208416		 SUPPL-1 ABIRATERONE ACETATE DR REDDYS Labeling Approval
12/20/2021 ABIRATERONE ACETATE
ANDA #208416		 SUPPL-5 ABIRATERONE ACETATE DR REDDYS Labeling Approval
12/20/2021 VOCABRIA
NDA #212887		 SUPPL-4 CABOTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
12/20/2021 APRETUDE
NDA #215499		 ORIG-1 CABOTEGRAVIR VIIV HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
12/20/2021 XARELTO
NDA #215859		 ORIG-1 RIVAROXABAN JANSSEN PHARMS Type 3 - New Dosage Form Approval
12/21/2021 INDOMETHACIN
NDA #022536		 SUPPL-8 INDOMETHACIN FRESENIUS KABI USA Labeling Approval
12/21/2021 CLOPIDOGREL BISULFATE
ANDA #076273		 SUPPL-29 CLOPIDOGREL BISULFATE DR REDDYS Labeling Approval
12/21/2021 IRBESARTAN
ANDA #077466		 SUPPL-11 IRBESARTAN SANDOZ Labeling Approval
12/21/2021 CLOPIDOGREL BISULFATE
ANDA #202266		 SUPPL-8 CLOPIDOGREL BISULFATE CHARTWELL RX Labeling Approval
12/21/2021 CYPROHEPTADINE HYDROCHLORIDE
ANDA #205431		 ORIG-1 CYPROHEPTADINE HYDROCHLORIDE TRIS PHARMA INC Approval
12/21/2021 DIMETHYL FUMARATE
ANDA #210285		 ORIG-1 DIMETHYL FUMARATE SAWAI USA Approval
12/21/2021 ASPARLAS
BLA #761102		 SUPPL-8 CALASPARGASE PEGOL-MKNL SERVIER PHARMA LLC Approval
12/21/2021 RYBREVANT
BLA #761210		 SUPPL-1 AMIVANTAMAB-VMJW JANSSEN BIOTECH Approval
12/22/2021 OCTREOSCAN
NDA #020314		 SUPPL-14 INDIUM IN-111 PENTETREOTIDE KIT CURIUM Labeling Approval
12/22/2021 CEREZYME
BLA #020367		 SUPPL-119 IMIGLUCERASE GENZYME Approval
12/22/2021 EPIVIR-HBV
NDA #021003		 SUPPL-23 LAMIVUDINE GLAXOSMITHKLINE Labeling Approval
12/22/2021 EPIVIR-HBV
NDA #021004		 SUPPL-23 LAMIVUDINE GLAXOSMITHKLINE Labeling Approval
12/22/2021 VANCOCIN HYDROCHLORIDE
NDA #050606		 SUPPL-39 VANCOMYCIN HYDROCHLORIDE ANI PHARMS Labeling Approval
12/22/2021 VERAPAMIL HYDROCHLORIDE
ANDA #078906		 SUPPL-10 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
12/22/2021 VERAPAMIL HYDROCHLORIDE
ANDA #090700		 SUPPL-7 VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
12/22/2021 COSENTYX
BLA #125504		 SUPPL-50 SECUKINUMAB NOVARTIS PHARMS CORP Approval
12/22/2021 COSENTYX
BLA #125504		 SUPPL-51 SECUKINUMAB NOVARTIS PHARMS CORP Approval
12/22/2021 TRANEXAMIC ACID
ANDA #202093		 SUPPL-9 TRANEXAMIC ACID ACTAVIS LABS FL INC Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-1 RITONAVIR CIPLA Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-2 RITONAVIR CIPLA Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-3 RITONAVIR CIPLA Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-4 RITONAVIR CIPLA Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-6 RITONAVIR CIPLA Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-7 RITONAVIR CIPLA Labeling Approval
12/22/2021 RITONAVIR
ANDA #202573		 SUPPL-9 RITONAVIR CIPLA Labeling Approval
12/22/2021 VALSARTAN
ANDA #202728		 SUPPL-8 VALSARTAN TORRENT Labeling Approval
12/22/2021 TEMOZOLOMIDE
ANDA #204159		 SUPPL-2 TEMOZOLOMIDE APOTEX Labeling Approval
12/22/2021 VELTASSA
NDA #205739		 SUPPL-35 PATIROMER SORBITEX CALCIUM VIFOR PHARMA Labeling Approval
12/22/2021 PIPERACILLIN AND TAZOBACTAM
ANDA #206996		 SUPPL-6 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WOCKHARDT BIO AG Labeling Approval
12/22/2021 VALPROATE SODIUM
ANDA #208120		 ORIG-1 VALPROATE SODIUM MYLAN Approval
12/22/2021 ROFLUMILAST
ANDA #208257		 SUPPL-1 ROFLUMILAST MYLAN Labeling Approval
12/22/2021 ROFLUMILAST
ANDA #208257		 SUPPL-2 ROFLUMILAST MYLAN Labeling Approval
12/22/2021 NETSPOT
NDA #208547		 SUPPL-24 GALLIUM DOTATATE GA-68 AAA USA INC Labeling Approval
12/22/2021 TYMLOS
NDA #208743		 SUPPL-10 ABALOPARATIDE RADIUS Efficacy Approval
12/22/2021 TERIFLUNOMIDE
ANDA #209601		 SUPPL-3 TERIFLUNOMIDE APOTEX Labeling Approval
12/22/2021 TERIFLUNOMIDE
ANDA #209601		 SUPPL-4 TERIFLUNOMIDE APOTEX Labeling Approval
12/22/2021 BUSULFAN
ANDA #210448		 SUPPL-1 BUSULFAN APOTEX Labeling Approval
12/22/2021 GALLIUM GA 68 EDOTREOTIDE
NDA #210828		 SUPPL-2 GALLIUM GA-68 EDOTREOTIDE UIHC PET IMAGING Labeling Approval
12/22/2021 DETECTNET
NDA #213227		 SUPPL-1 COPPER CU-64 DOTATATE RADIOMEDIX Labeling Approval
12/22/2021 AFATINIB
ANDA #213499		 ORIG-1 AFATINIB QILU PHARM CO LTD Tentative Approval
12/22/2021 EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #213541		 ORIG-1 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE LAURUS Approval
12/22/2021 KOSELUGO
NDA #213756		 SUPPL-3 SELUMETINIB SULFATE ASTRAZENECA Labeling Approval
12/22/2021 LEQVIO
NDA #214012		 ORIG-1 INCLISIRAN SODIUM NOVARTIS Type 1 - New Molecular Entity Approval
12/22/2021 DUPIXENT
BLA #761055		 SUPPL-21 DUPILUMAB REGENERON PHARMACEUTICALS Approval
12/22/2021 DUPIXENT
BLA #761055		 SUPPL-27 DUPILUMAB REGENERON PHARMACEUTICALS Approval
12/22/2021 DUPIXENT
BLA #761055		 SUPPL-33 DUPILUMAB REGENERON PHARMACEUTICALS Approval
12/23/2021 VALCYTE
NDA #021304		 SUPPL-17 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
12/23/2021 VALCYTE
NDA #022257		 SUPPL-12 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
12/23/2021 LISINOPRIL
ANDA #075903		 SUPPL-23 LISINOPRIL ASCENT PHARMS INC Manufacturing (CMC) Approval
12/23/2021 SEVELAMER CARBONATE
ANDA #201513		 ORIG-1 SEVELAMER CARBONATE LUPIN LTD Approval
12/23/2021 TRANEXAMIC ACID
ANDA #202286		 SUPPL-5 TRANEXAMIC ACID APOTEX Labeling Approval
12/23/2021 TESTOSTERONE CYPIONATE
ANDA #210362		 SUPPL-2 TESTOSTERONE CYPIONATE CIPLA Labeling Approval
12/23/2021 PRAZOSIN HYDROCHLORIDE
ANDA #214608		 ORIG-1 PRAZOSIN HYDROCHLORIDE GRANULES Approval
12/23/2021 TASCENSO ODT
NDA #214962		 ORIG-2 FINGOLIMOD LAURYL SULFATE CYCLE Approval
12/27/2021 SITAGLIPTIN PHOSPHATE
ANDA #202387		 ORIG-1 SITAGLIPTIN PHOSPHATE SANDOZ INC Tentative Approval
12/27/2021 REXULTI
NDA #205422		 SUPPL-7 BREXPIPRAZOLE OTSUKA Efficacy Approval
12/27/2021 ELIGLUSTAT TARTRATE
ANDA #212474		 ORIG-1 ELIGLUSTAT TARTRATE TEVA PHARMS USA INC Approval
12/27/2021 SIROLIMUS
ANDA #215016		 ORIG-1 SIROLIMUS TORRENT Approval
12/27/2021 ADBRY
BLA #761180		 ORIG-1 TRALOKINUMAB LEO PHARMA AS Approval
12/28/2021 HIPREX
NDA #017681		 SUPPL-19 METHENAMINE HIPPURATE SS PHARMA Manufacturing (CMC) Approval
12/28/2021 EOVIST
NDA #022090		 SUPPL-20 GADOXETATE DISODIUM BAYER HLTHCARE Labeling Approval
12/28/2021 DOXERCALCIFEROL
ANDA #203875		 SUPPL-4 DOXERCALCIFEROL SUN PHARM Manufacturing (CMC) Approval
12/28/2021 BIJUVA
NDA #210132		 SUPPL-6 ESTRADIOL; PROGESTERONE MAYNE PHARMA Efficacy Approval
12/28/2021 ALBUTEROL SULFATE
ANDA #214531		 ORIG-1 ALBUTEROL SULFATE RITEDOSE CORP Approval
12/28/2021 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #215771		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE GRANULES Approval
12/29/2021 CABAZITAXEL
NDA #207949		 ORIG-1 CABAZITAXEL ACCORD HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
12/29/2021 CALCIUM GLUCONATE
NDA #208418		 SUPPL-11 CALCIUM GLUCONATE FRESENIUS KABI USA Labeling Approval
12/29/2021 CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #208418		 SUPPL-11 CALCIUM GLUCONATE FRESENIUS KABI USA Labeling Approval
12/30/2021 AFINITOR
NDA #022334		 SUPPL-50 EVEROLIMUS NOVARTIS Efficacy Approval
12/30/2021 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #201295		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE TRIS PHARMA INC Approval
12/30/2021 IVABRADINE HYDROCHLORIDE
ANDA #214051		 ORIG-1 IVABRADINE HYDROCHLORIDE INGENUS PHARMS LLC Approval
12/30/2021 RECORLEV
NDA #214133		 ORIG-1 LEVOKETOCONAZOLE STRONGBRIDGE Type 2 - New Active Ingredient Approval
12/30/2021 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #214928		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE PRINSTON INC Approval
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