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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
March 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 May 01, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/02/2020 ALEVE
NDA #020204		 SUPPL-70 NAPROXEN SODIUM BAYER Labeling Approval
03/02/2020 SUBUTEX
NDA #020732		 SUPPL-23 BUPRENORPHINE HYDROCHLORIDE INDIVIOR REMS Approval
03/02/2020 SUBOXONE
NDA #020733		 SUPPL-27 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
03/02/2020 CAFCIT
NDA #020793		 SUPPL-19 CAFFEINE CITRATE HIKMA Labeling Approval
03/02/2020 SUBOXONE
NDA #022410		 SUPPL-39 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
03/02/2020 DORYX
NDA #050582		 SUPPL-31 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
03/02/2020 CARVEDILOL
ANDA #076373		 SUPPL-16 CARVEDILOL TEVA Labeling Approval
03/02/2020 KURVELO
ANDA #091408		 SUPPL-7 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Labeling Approval
03/02/2020 KURVELO
ANDA #091408		 SUPPL-9 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Labeling Approval
03/02/2020 KURVELO
ANDA #091408		 SUPPL-10 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Manufacturing (CMC) Approval
03/02/2020 DICLOFENAC POTASSIUM
ANDA #204648		 SUPPL-1 DICLOFENAC POTASSIUM BIONPHARMA Labeling Approval
03/02/2020 SILDENAFIL CITRATE
ANDA #207178		 ORIG-1 SILDENAFIL CITRATE APPCO Approval
03/02/2020 DEXTENZA
NDA #208742		 SUPPL-5 DEXAMETHASONE OCULAR THERAPEUTIX Labeling Approval
03/02/2020 APIXABAN
ANDA #210082		 ORIG-1 APIXABAN DR REDDYS LABS INC Tentative Approval
03/02/2020 AMANTADINE HYDROCHLORIDE
ANDA #210129		 ORIG-1 AMANTADINE HYDROCHLORIDE RISING Approval
03/02/2020 SYMTUZA
NDA #210455		 SUPPL-9 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE JANSSEN PRODS Efficacy Approval
03/02/2020 SARCLISA
BLA #761113		 ORIG-1 ISATUXIMAB-IRFC SANOFI AVENTIS US Approval
03/03/2020 SINEMET
NDA #017555		 SUPPL-72 CARBIDOPA; LEVODOPA ORGANON Manufacturing (CMC) Approval
03/03/2020 CAPTOPRIL
ANDA #074434		 SUPPL-16 CAPTOPRIL AUROBINDO PHARMA USA Labeling Approval
03/03/2020 CAPTOPRIL
ANDA #074505		 SUPPL-31 CAPTOPRIL HIKMA INTL PHARMS Labeling Approval
03/03/2020 CAPTOPRIL
ANDA #074737		 SUPPL-11 CAPTOPRIL COREPHARMA Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE
ANDA #076601		 SUPPL-8 CETIRIZINE HYDROCHLORIDE TARO Labeling Approval
03/03/2020 CARVEDILOL
ANDA #076989		 SUPPL-5 CARVEDILOL SUN PHARM INDS LTD Labeling Approval
03/03/2020 LORATADINE REDIDOSE
ANDA #077153		 SUPPL-10 LORATADINE SUN PHARM INDS LTD Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE
ANDA #077279		 SUPPL-5 CETIRIZINE HYDROCHLORIDE TEVA PHARMS Labeling Approval
03/03/2020 CARVEDILOL
ANDA #077316		 SUPPL-16 CARVEDILOL MYLAN Labeling Approval
03/03/2020 ROPINIROLE HYDROCHLORIDE
ANDA #077460		 SUPPL-8 ROPINIROLE HYDROCHLORIDE COSETTE Labeling Approval
03/03/2020 CARVEDILOL
ANDA #077474		 SUPPL-3 CARVEDILOL CHARTWELL MOLECULAR Labeling Approval
03/03/2020 CARVEDILOL
ANDA #077614		 SUPPL-17 CARVEDILOL ZYDUS PHARMS USA INC Labeling Approval
03/03/2020 CARVEDILOL
ANDA #078332		 SUPPL-24 CARVEDILOL AUROBINDO PHARMA Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE
ANDA #078398		 SUPPL-7 CETIRIZINE HYDROCHLORIDE PADAGIS US Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE
ANDA #078488		 SUPPL-6 CETIRIZINE HYDROCHLORIDE BIONPHARMA Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #078680		 SUPPL-8 CETIRIZINE HYDROCHLORIDE UNICHEM Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE HIVES
ANDA #078680		 SUPPL-8 CETIRIZINE HYDROCHLORIDE UNICHEM Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE
ANDA #078876		 SUPPL-5 CETIRIZINE HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
03/03/2020 ROPINIROLE HYDROCHLORIDE
ANDA #078881		 SUPPL-18 ROPINIROLE HYDROCHLORIDE MYLAN Labeling Approval
03/03/2020 ROPINIROLE HYDROCHLORIDE
ANDA #078881		 SUPPL-20 ROPINIROLE HYDROCHLORIDE MYLAN Labeling Approval
03/03/2020 ROPINIROLE HYDROCHLORIDE
ANDA #079050		 SUPPL-4 ROPINIROLE HYDROCHLORIDE CHARTWELL RX Labeling Approval
03/03/2020 ALTAVERA
ANDA #079102		 SUPPL-9 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
03/03/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-28 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
03/03/2020 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #203330		 SUPPL-5 FEXOFENADINE HYDROCHLORIDE P AND L Labeling Approval
03/03/2020 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #203330		 SUPPL-5 FEXOFENADINE HYDROCHLORIDE P AND L Labeling Approval
03/03/2020 LANSOPRAZOLE
ANDA #205868		 SUPPL-1 LANSOPRAZOLE INVENTIA Labeling Approval
03/03/2020 LANSOPRAZOLE
ANDA #205868		 SUPPL-3 LANSOPRAZOLE INVENTIA Labeling Approval
03/03/2020 KHAPZORY
NDA #211226		 SUPPL-2 LEVOLEUCOVORIN ACROTECH BIOPHARMA Labeling Approval
03/03/2020 METFORMIN HYDROCHLORIDE
ANDA #211309		 ORIG-1 METFORMIN HYDROCHLORIDE SAPTALIS PHARMS Approval
03/03/2020 TETRACYCLINE HYDROCHLORIDE
ANDA #212635		 ORIG-1 TETRACYCLINE HYDROCHLORIDE STRIDES PHARMA Approval
03/04/2020 REMERON
NDA #020415		 SUPPL-29 MIRTAZAPINE ORGANON Labeling Approval
03/04/2020 REMERON SOLTAB
NDA #021208		 SUPPL-19 MIRTAZAPINE ORGANON USA ORGANON Labeling Approval
03/04/2020 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-83 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
03/04/2020 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-41 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
03/04/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077157		 SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TEVA PHARMS Labeling Approval
03/04/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077157		 SUPPL-15 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TEVA PHARMS Labeling Approval
03/04/2020 ROPINIROLE HYDROCHLORIDE
ANDA #078230		 SUPPL-7 ROPINIROLE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
03/04/2020 ROPINIROLE HYDROCHLORIDE
ANDA #078230		 SUPPL-8 ROPINIROLE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
03/04/2020 ROPINIROLE HYDROCHLORIDE
ANDA #078230		 SUPPL-9 ROPINIROLE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
03/04/2020 GEMCITABINE HYDROCHLORIDE
ANDA #078339		 SUPPL-8 GEMCITABINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/04/2020 GEMCITABINE HYDROCHLORIDE
ANDA #078339		 SUPPL-10 GEMCITABINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/04/2020 GEMCITABINE HYDROCHLORIDE
ANDA #078339		 SUPPL-11 GEMCITABINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/04/2020 OXYCODONE HYDROCHLORIDE
ANDA #203447		 SUPPL-4 OXYCODONE HYDROCHLORIDE ANI PHARMS Labeling Approval
03/04/2020 ACTICLATE
NDA #205931		 SUPPL-5 DOXYCYCLINE HYCLATE CHARTWELL RX Labeling Approval
03/04/2020 RYDAPT
NDA #207997		 SUPPL-4 MIDOSTAURIN NOVARTIS Labeling Approval
03/04/2020 ACTICLATE CAP
NDA #208253		 SUPPL-3 DOXYCYCLINE HYCLATE CHARTWELL RX Labeling Approval
03/04/2020 DESOXIMETASONE
ANDA #209595		 ORIG-1 DESOXIMETASONE COSETTE Approval
03/04/2020 DOXYCYCLINE HYCLATE
ANDA #210537		 ORIG-1 DOXYCYCLINE HYCLATE ALEMBIC Approval
03/04/2020 HYDROCORTISONE VALERATE
ANDA #211764		 ORIG-1 HYDROCORTISONE VALERATE COSETTE Approval
03/04/2020 POTASSIUM CHLORIDE
ANDA #211797		 ORIG-1 POTASSIUM CHLORIDE GRANULES Approval
03/04/2020 DURYSTA
NDA #211911		 ORIG-1 BIMATOPROST ABBVIE Type 3 - New Dosage Form Approval
03/04/2020 OSELTAMIVIR PHOSPHATE
ANDA #212739		 ORIG-1 OSELTAMIVIR PHOSPHATE SUNSHINE Approval
03/04/2020 THIOTEPA
ANDA #213049		 ORIG-1 THIOTEPA MSN Approval
03/05/2020 CIPRO
NDA #019537		 SUPPL-90 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
03/05/2020 CIPRO
NDA #019847		 SUPPL-61 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/05/2020 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-70 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/05/2020 CIPRO
NDA #020780		 SUPPL-47 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
03/05/2020 CIPRO XR
NDA #021473		 SUPPL-41 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
03/05/2020 ADREVIEW
NDA #022290		 SUPPL-5 IOBENGUANE SULFATE I-123 GE HEALTHCARE Labeling Approval
03/05/2020 LEVORPHANOL TARTRATE
ANDA #074278		 SUPPL-16 LEVORPHANOL TARTRATE HIKMA Labeling Approval
03/05/2020 PREDNISOLONE SODIUM PHOSPHATE
ANDA #075988		 SUPPL-6 PREDNISOLONE SODIUM PHOSPHATE CHARTWELL RX Manufacturing (CMC) Approval
03/05/2020 CARBOPLATIN
ANDA #077861		 SUPPL-1 CARBOPLATIN TEYRO LABS Labeling Approval
03/05/2020 ENBREL
BLA #103795		 SUPPL-5574 ETANERCEPT IMMUNEX Approval
03/05/2020 ENBREL
BLA #103795		 SUPPL-5577 ETANERCEPT IMMUNEX Approval
03/05/2020 JEVTANA KIT
NDA #201023		 SUPPL-23 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
03/05/2020 BUPROPION HYDROCHLORIDE
ANDA #201567		 SUPPL-13 BUPROPION HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
03/05/2020 CLINDAMYCIN PHOSPHATE
ANDA #203343		 SUPPL-1 CLINDAMYCIN PHOSPHATE VINTAGE PHARMS Labeling Approval
03/05/2020 CLINDAMYCIN PHOSPHATE
ANDA #203343		 SUPPL-2 CLINDAMYCIN PHOSPHATE VINTAGE PHARMS Labeling Approval
03/05/2020 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204473		 SUPPL-1 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
03/05/2020 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #204473		 SUPPL-3 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
03/05/2020 SOVALDI
NDA #204671		 SUPPL-17 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
03/05/2020 HARVONI
NDA #205834		 SUPPL-32 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
03/05/2020 POTASSIUM CHLORIDE
NDA #206814		 SUPPL-9 POTASSIUM CHLORIDE GENUS LIFESCIENCES Labeling Approval
03/05/2020 POKONZA
NDA #208019		 SUPPL-3 POTASSIUM CHLORIDE PHARMA RES SOFTWARE Labeling Approval
03/05/2020 POTASSIUM CHLORIDE
NDA #208019		 SUPPL-3 POTASSIUM CHLORIDE PHARMA RES SOFTWARE Labeling Approval
03/05/2020 LUMIFY
NDA #208144		 SUPPL-6 BRIMONIDINE TARTRATE BAUSCH AND LOMB INC Labeling Approval
03/05/2020 LORATADINE
ANDA #210088		 SUPPL-7 LORATADINE SUN PHARM Labeling Approval
03/05/2020 HARVONI
NDA #212477		 SUPPL-3 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
03/05/2020 SOVALDI
NDA #212480		 SUPPL-2 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
03/06/2020 ORAPRED ODT
NDA #021959		 SUPPL-11 PREDNISOLONE SODIUM PHOSPHATE CONCORDIA PHARMS INC Labeling Approval
03/06/2020 SOTALOL HYDROCHLORIDE
NDA #022306		 SUPPL-5 SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC Efficacy Approval
03/06/2020 EDARBI
NDA #200796		 SUPPL-12 AZILSARTAN KAMEDOXOMIL AZURITY Labeling Approval
03/06/2020 GRANISETRON HYDROCHLORIDE
ANDA #202647		 ORIG-1 GRANISETRON HYDROCHLORIDE YUNG SHIN PHARM Approval
03/06/2020 MELPHALAN HYDROCHLORIDE
ANDA #209323		 ORIG-1 MELPHALAN HYDROCHLORIDE ACTAVIS LLC Approval
03/06/2020 CELECOXIB
ANDA #211412		 ORIG-1 CELECOXIB YILING Approval
03/06/2020 ISTURISA
NDA #212801		 ORIG-1 OSILODROSTAT PHOSPHATE RECORDATI RARE Type 1 - New Molecular Entity Approval
03/09/2020 NORDITROPIN
BLA #021148		 SUPPL-53 SOMATROPIN NOVO NORDISK INC Approval
03/09/2020 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-53 SOMATROPIN NOVO NORDISK INC Approval
03/09/2020 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-53 SOMATROPIN NOVO NORDISK INC Approval
03/09/2020 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-102 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
03/09/2020 CEFDINIR
ANDA #065332		 SUPPL-14 CEFDINIR TEVA PHARMS Labeling Approval
03/09/2020 CEFDINIR
ANDA #065332		 SUPPL-16 CEFDINIR TEVA PHARMS Labeling Approval
03/09/2020 CEFDINIR
ANDA #065473		 SUPPL-5 CEFDINIR AUROBINDO PHARMA Labeling Approval
03/09/2020 CEFDINIR
ANDA #065473		 SUPPL-6 CEFDINIR AUROBINDO PHARMA Labeling Approval
03/09/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #076855		 SUPPL-12 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/09/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #076855		 SUPPL-14 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/09/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #076855		 SUPPL-17 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
03/09/2020 TOLTERODINE TARTRATE
ANDA #079141		 SUPPL-1 TOLTERODINE TARTRATE TEVA PHARMS USA Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079145		 SUPPL-3 ROSUVASTATIN CALCIUM APOTEX Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079145		 SUPPL-6 ROSUVASTATIN CALCIUM APOTEX Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079170		 SUPPL-3 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079170		 SUPPL-6 ROSUVASTATIN CALCIUM AUROBINDO PHARMA LTD Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079171		 SUPPL-2 ROSUVASTATIN CALCIUM SANDOZ Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079171		 SUPPL-5 ROSUVASTATIN CALCIUM SANDOZ Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079172		 SUPPL-1 ROSUVASTATIN CALCIUM GLENMARK PHARMS Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079172		 SUPPL-2 ROSUVASTATIN CALCIUM GLENMARK PHARMS Labeling Approval
03/09/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #090973		 SUPPL-12 OMEGA-3-ACID ETHYL ESTERS APOTEX Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #201619		 SUPPL-2 ROSUVASTATIN CALCIUM TORRENT Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #201619		 SUPPL-3 ROSUVASTATIN CALCIUM TORRENT Labeling Approval
03/09/2020 EDARBYCLOR
NDA #202331		 SUPPL-16 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE AZURITY Labeling Approval
03/09/2020 TOLTERODINE TARTRATE
ANDA #203016		 SUPPL-3 TOLTERODINE TARTRATE TORRENT Labeling Approval
03/09/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #203893		 SUPPL-8 OMEGA-3-ACID ETHYL ESTERS STRIDES PHARMA Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #205587		 SUPPL-1 ROSUVASTATIN CALCIUM LUPIN Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #205587		 SUPPL-2 ROSUVASTATIN CALCIUM LUPIN Labeling Approval
03/09/2020 OFEV
NDA #205832		 SUPPL-13 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Efficacy Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #207062		 SUPPL-1 ROSUVASTATIN CALCIUM RENATA Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #207062		 SUPPL-6 ROSUVASTATIN CALCIUM RENATA Labeling Approval
03/09/2020 ICATIBANT ACETATE
ANDA #211021		 ORIG-1 ICATIBANT ACETATE JIANGSU HANSOH PHARM Approval
03/09/2020 FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
NDA #211039		 ORIG-1 BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM BAUSCH LOMB IRELAND Type 4 - New Combination Approval
03/09/2020 TALZENNA
NDA #211651		 SUPPL-5 TALAZOPARIB TOSYLATE PFIZER Efficacy Approval
03/10/2020 XARELTO
NDA #022406		 SUPPL-35 RIVAROXABAN JANSSEN PHARMS Labeling Approval
03/10/2020 YERVOY
BLA #125377		 SUPPL-108 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
03/10/2020 OPDIVO
BLA #125554		 SUPPL-78 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/10/2020 PRALUENT
BLA #125559		 SUPPL-24 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
03/10/2020 XARELTO
NDA #202439		 SUPPL-31 RIVAROXABAN JANSSEN PHARMS Efficacy Approval
03/10/2020 VARDENAFIL HYDROCHLORIDE
ANDA #205988		 ORIG-1 VARDENAFIL HYDROCHLORIDE MACLEODS PHARMS LTD Approval
03/10/2020 ROSUVASTATIN CALCIUM
ANDA #206465		 SUPPL-1 ROSUVASTATIN CALCIUM ALKEM LABS LTD Labeling Approval
03/10/2020 ROSUVASTATIN CALCIUM
ANDA #206465		 SUPPL-2 ROSUVASTATIN CALCIUM ALKEM LABS LTD Labeling Approval
03/10/2020 ROSUVASTATIN CALCIUM
ANDA #207453		 SUPPL-1 ROSUVASTATIN CALCIUM CADILA PHARMS LTD Labeling Approval
03/10/2020 ROSUVASTATIN CALCIUM
ANDA #207453		 SUPPL-3 ROSUVASTATIN CALCIUM CADILA PHARMS LTD Labeling Approval
03/10/2020 ROSUVASTATIN CALCIUM
ANDA #207453		 SUPPL-4 ROSUVASTATIN CALCIUM CADILA PHARMS LTD Labeling Approval
03/10/2020 GOCOVRI
NDA #208944		 SUPPL-3 AMANTADINE HYDROCHLORIDE ADAMAS OPERATIONS Labeling Approval
03/10/2020 AMANTADINE HYDROCHLORIDE
ANDA #210215		 ORIG-1 AMANTADINE HYDROCHLORIDE ATHEM Approval
03/11/2020 BUSULFEX
NDA #020954		 SUPPL-20 BUSULFAN OTSUKA PHARM Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060		 SUPPL-16 VALPROIC ACID HIKMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060		 SUPPL-17 VALPROIC ACID HIKMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060		 SUPPL-18 VALPROIC ACID HIKMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060		 SUPPL-19 VALPROIC ACID HIKMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060		 SUPPL-20 VALPROIC ACID HIKMA Labeling Approval
03/11/2020 CAPTOPRIL
ANDA #074532		 SUPPL-10 CAPTOPRIL WOCKHARDT Labeling Approval
03/11/2020 CAPTOPRIL
ANDA #074532		 SUPPL-12 CAPTOPRIL WOCKHARDT Labeling Approval
03/11/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #077561		 SUPPL-10 ZIPRASIDONE HYDROCHLORIDE APOTEX Labeling Approval
03/11/2020 ZIPRASIDONE HYDROCHLORIDE
ANDA #077561		 SUPPL-12 ZIPRASIDONE HYDROCHLORIDE APOTEX Labeling Approval
03/11/2020 CARVEDILOL
ANDA #078165		 SUPPL-9 CARVEDILOL RUBICON Labeling Approval
03/11/2020 HUMIRA
BLA #125057		 SUPPL-415 ADALIMUMAB ABBVIE INC Approval
03/11/2020 ZALTRAP
BLA #125418		 SUPPL-46 ZIV-AFLIBERCEPT SANOFI AVENTIS US Approval
03/11/2020 PREDNISOLONE SODIUM PHOSPHATE
ANDA #204962		 ORIG-1 PREDNISOLONE SODIUM PHOSPHATE PHARM ASSOC Approval
03/11/2020 RASUVO
NDA #205776		 SUPPL-4 METHOTREXATE MEDEXUS Labeling Approval
03/11/2020 DABIGATRAN ETEXILATE MESYLATE
ANDA #208040		 ORIG-1 DABIGATRAN ETEXILATE MESYLATE ALKEM LABS LTD Approval
03/11/2020 DABIGATRAN ETEXILATE MESYLATE
ANDA #208040		 ORIG-2 DABIGATRAN ETEXILATE MESYLATE ALKEM LABS LTD Tentative Approval
03/11/2020 CLINDAMYCIN PHOSPHATE
ANDA #210004		 ORIG-1 CLINDAMYCIN PHOSPHATE TARO Approval
03/11/2020 AMPHETAMINE SULFATE
ANDA #211861		 ORIG-1 AMPHETAMINE SULFATE PRINSTON INC Approval
03/12/2020 THYROGEN
BLA #020898		 SUPPL-63 THYROTROPIN ALFA GENZYME Approval
03/12/2020 THYROGEN
BLA #020898		 SUPPL-65 THYROTROPIN ALFA GENZYME Approval
03/12/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #077471		 SUPPL-9 HYDROMORPHONE HYDROCHLORIDE GENUS Labeling Approval
03/12/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #077471		 SUPPL-13 HYDROMORPHONE HYDROCHLORIDE GENUS Labeling Approval
03/12/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #077471		 SUPPL-16 HYDROMORPHONE HYDROCHLORIDE GENUS Labeling Approval
03/12/2020 ZONISAMIDE
ANDA #077625		 SUPPL-7 ZONISAMIDE ZYDUS LIFESCIENCES Labeling Approval
03/12/2020 ZONISAMIDE
ANDA #077869		 SUPPL-9 ZONISAMIDE INVAGEN PHARMS Labeling Approval
03/12/2020 CARVEDILOL
ANDA #078217		 SUPPL-4 CARVEDILOL LUPIN Labeling Approval
03/12/2020 CARVEDILOL
ANDA #078217		 SUPPL-5 CARVEDILOL LUPIN Labeling Approval
03/12/2020 VALACYCLOVIR HYDROCHLORIDE
ANDA #090370		 SUPPL-9 VALACYCLOVIR HYDROCHLORIDE WATSON LABS INC Labeling Approval
03/12/2020 CETIRIZINE HYDROCHLORIDE
ANDA #090766		 SUPPL-3 CETIRIZINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #200790		 SUPPL-3 VALGANCICLOVIR HYDROCHLORIDE STRIDES PHARMA Labeling Approval
03/12/2020 VENLAFAXINE HYDROCHLORIDE
ANDA #203332		 ORIG-1 VENLAFAXINE HYDROCHLORIDE INVENTIA HLTHCARE Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #204750		 SUPPL-2 VALGANCICLOVIR HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #204750		 SUPPL-3 VALGANCICLOVIR HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #204750		 SUPPL-5 VALGANCICLOVIR HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #205166		 SUPPL-6 VALGANCICLOVIR HYDROCHLORIDE HETERO LABS LTD V Labeling Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #205220		 SUPPL-2 VALGANCICLOVIR HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
03/12/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #205220		 SUPPL-4 VALGANCICLOVIR HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
03/12/2020 ROSUVASTATIN CALCIUM
ANDA #206434		 SUPPL-2 ROSUVASTATIN CALCIUM ACCORD HLTHCARE Labeling Approval
03/12/2020 ROSUVASTATIN CALCIUM
ANDA #206434		 SUPPL-5 ROSUVASTATIN CALCIUM ACCORD HLTHCARE Labeling Approval
03/12/2020 VIGABATRIN
ANDA #208218		 SUPPL-1 VIGABATRIN PAR PHARM INC Labeling Approval
03/12/2020 VIGABATRIN
ANDA #208218		 SUPPL-6 VIGABATRIN PAR PHARM INC Labeling Approval
03/12/2020 VIGABATRIN
ANDA #208218		 SUPPL-8 VIGABATRIN PAR PHARM INC Labeling Approval
03/13/2020 BIO-TROPIN
BLA #019774		 SUPPL-53 SOMATROPIN FERRING Approval
03/13/2020 ZOMACTON
BLA #019774		 SUPPL-53 SOMATROPIN FERRING Approval
03/13/2020 FORTESTA
NDA #021463		 SUPPL-22 TESTOSTERONE ENDO PHARMS Labeling Approval
03/13/2020 AVEED
NDA #022219		 SUPPL-13 TESTOSTERONE UNDECANOATE ENDO PHARMS INC Labeling Approval
03/13/2020 RITUXAN
BLA #103705		 SUPPL-5458 RITUXIMAB GENENTECH Approval
03/13/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845		 SUPPL-10 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
03/13/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845		 SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
03/13/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #203511		 SUPPL-3 VALGANCICLOVIR HYDROCHLORIDE DR REDDYS Labeling Approval
03/13/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #203511		 SUPPL-4 VALGANCICLOVIR HYDROCHLORIDE DR REDDYS Labeling Approval
03/13/2020 OXYBUTYNIN CHLORIDE
ANDA #204010		 SUPPL-10 OXYBUTYNIN CHLORIDE AMNEAL PHARMS Labeling Approval
03/13/2020 ARIKAYCE KIT
NDA #207356		 SUPPL-4 AMIKACIN SULFATE INSMED INC Labeling Approval
03/13/2020 TEPADINA
NDA #208264		 SUPPL-3 THIOTEPA ADIENNE SA Manufacturing (CMC) Approval
03/13/2020 ROMIDEPSIN
NDA #208574		 ORIG-1 ROMIDEPSIN TEVA PHARMS USA INC Type 5 - New Formulation or New Manufacturer Approval
03/13/2020 ROMIDEPSIN
NDA #208574		 ORIG-2 ROMIDEPSIN TEVA PHARMS USA INC Efficacy Approval
03/15/2020 MEMANTINE HYDROCHLORIDE
ANDA #203293		 SUPPL-1 MEMANTINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
03/15/2020 MEMANTINE HYDROCHLORIDE
ANDA #205905		 SUPPL-1 MEMANTINE HYDROCHLORIDE SUN PHARM Labeling Approval
03/15/2020 MEMANTINE HYDROCHLORIDE
ANDA #205905		 SUPPL-3 MEMANTINE HYDROCHLORIDE SUN PHARM Labeling Approval
03/15/2020 MEMANTINE HYDROCHLORIDE
ANDA #206032		 SUPPL-1 MEMANTINE HYDROCHLORIDE RISING Labeling Approval
03/15/2020 MEMANTINE HYDROCHLORIDE
ANDA #206032		 SUPPL-4 MEMANTINE HYDROCHLORIDE RISING Labeling Approval
03/15/2020 RANOLAZINE
ANDA #208862		 SUPPL-3 RANOLAZINE ACTAVIS ELIZABETH Labeling Approval
03/15/2020 ALBENDAZOLE
ANDA #210011		 SUPPL-2 ALBENDAZOLE STRIDES PHARMA Labeling Approval
03/16/2020 KUVAN
NDA #022181		 SUPPL-20 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Labeling Approval
03/16/2020 KIONEX
ANDA #040029		 SUPPL-17 SODIUM POLYSTYRENE SULFONATE ANI PHARMS Labeling Approval
03/16/2020 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
ANDA #040302		 SUPPL-16 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/16/2020 ALENDRONATE SODIUM
ANDA #077982		 SUPPL-11 ALENDRONATE SODIUM APOTEX Labeling Approval
03/16/2020 NARATRIPTAN
ANDA #091441		 SUPPL-2 NARATRIPTAN HYDROCHLORIDE ORBION PHARMS Labeling Approval
03/16/2020 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #200797		 SUPPL-4 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Labeling Approval
03/16/2020 ETHOSUXIMIDE
ANDA #200892		 SUPPL-2 ETHOSUXIMIDE HERITAGE PHARMS INC Labeling Approval
03/16/2020 FEXOFENADINE HYDROCHLORIDE
ANDA #201311		 SUPPL-3 FEXOFENADINE HYDROCHLORIDE P AND L Labeling Approval
03/16/2020 COLESEVELAM HYDROCHLORIDE
ANDA #202190		 SUPPL-1 COLESEVELAM HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
03/16/2020 COLESEVELAM HYDROCHLORIDE
ANDA #202190		 SUPPL-2 COLESEVELAM HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
03/16/2020 ZOLMITRIPTAN
ANDA #203772		 SUPPL-11 ZOLMITRIPTAN MACLEODS PHARMS LTD Labeling Approval
03/16/2020 METHADONE HYDROCHLORIDE
ANDA #204166		 ORIG-1 METHADONE HYDROCHLORIDE VISTAPHARM LLC Approval
03/16/2020 ZOLMITRIPTAN
ANDA #204336		 SUPPL-10 ZOLMITRIPTAN MACLEODS PHARMS LTD Labeling Approval
03/16/2020 KUVAN
NDA #205065		 SUPPL-6 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Labeling Approval
03/16/2020 ITRACONAZOLE
ANDA #205573		 SUPPL-2 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
03/16/2020 ITRACONAZOLE
ANDA #205573		 SUPPL-3 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
03/16/2020 ITRACONAZOLE
ANDA #205573		 SUPPL-6 ITRACONAZOLE AMNEAL PHARMS Labeling Approval
03/16/2020 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206180		 SUPPL-5 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN AUROBINDO PHARMA Labeling Approval
03/16/2020 CARFILZOMIB
ANDA #209425		 ORIG-1 CARFILZOMIB APOTEX Approval
03/16/2020 BUPROPION HYDROCHLORIDE
ANDA #210015		 SUPPL-4 BUPROPION HYDROCHLORIDE YICHANG HUMANWELL Labeling Approval
03/16/2020 COLESEVELAM HYDROCHLORIDE
ANDA #210316		 SUPPL-1 COLESEVELAM HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
03/16/2020 ETHOSUXIMIDE
ANDA #210654		 ORIG-1 ETHOSUXIMIDE PURACAP PHARM LLC Approval
03/16/2020 DOXYCYCLINE HYCLATE
ANDA #210664		 ORIG-1 DOXYCYCLINE HYCLATE ACELLA Approval
03/16/2020 LIDOCAINE
ANDA #211697		 ORIG-1 LIDOCAINE MACLEODS PHARMS LTD Approval
03/16/2020 NALOXONE HYDROCHLORIDE
ANDA #213209		 ORIG-1 NALOXONE HYDROCHLORIDE DR REDDYS Approval
03/17/2020 MANNITOL 10%
NDA #016269		 SUPPL-56 MANNITOL HOSPIRA Efficacy Approval
03/17/2020 MANNITOL 15%
NDA #016269		 SUPPL-56 MANNITOL HOSPIRA Efficacy Approval
03/17/2020 MANNITOL 20%
NDA #016269		 SUPPL-56 MANNITOL HOSPIRA Efficacy Approval
03/17/2020 MANNITOL 25%
NDA #016269		 SUPPL-56 MANNITOL HOSPIRA Efficacy Approval
03/17/2020 MANNITOL 5%
NDA #016269		 SUPPL-56 MANNITOL HOSPIRA Efficacy Approval
03/17/2020 ETHOSUXIMIDE
ANDA #040686		 SUPPL-7 ETHOSUXIMIDE EPIC PHARMA LLC Labeling Approval
03/17/2020 OXAZEPAM
ANDA #071026		 SUPPL-18 OXAZEPAM UNITED RES LABS Manufacturing (CMC) Approval
03/17/2020 PAROXETINE HYDROCHLORIDE
ANDA #077395		 SUPPL-12 PAROXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
03/17/2020 DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #087513		 SUPPL-14 DIPHENHYDRAMINE HYDROCHLORIDE PHARM ASSOC Manufacturing (CMC) Approval
03/17/2020 TETRABENAZINE
ANDA #206093		 ORIG-1 TETRABENAZINE APOTEX Approval
03/17/2020 VORTIOXETINE
ANDA #210993		 ORIG-1 VORTIOXETINE SANDOZ INC Tentative Approval
03/17/2020 BROMFENAC SODIUM
ANDA #211029		 ORIG-1 BROMFENAC SODIUM GLAND PHARMA LTD Approval
03/17/2020 TIBSOVO
NDA #211192		 SUPPL-2 IVOSIDENIB SERVIER Labeling Approval
03/17/2020 VERAPAMIL HYDROCHLORIDE
ANDA #213352		 ORIG-1 VERAPAMIL HYDROCHLORIDE NEPHRON Approval
03/18/2020 LUPRON DEPOT
NDA #020708		 SUPPL-38 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
03/18/2020 VIDAZA
NDA #050794		 SUPPL-32 AZACITIDINE BRISTOL-MYERS Labeling Approval
03/18/2020 BELSOMRA
NDA #204569		 SUPPL-7 SUVOREXANT MERCK SHARP DOHME Labeling Approval
03/18/2020 MEMANTINE HYDROCHLORIDE
ANDA #205825		 SUPPL-9 MEMANTINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
03/18/2020 VALACYCLOVIR HYDROCHLORIDE
ANDA #209553		 ORIG-1 VALACYCLOVIR HYDROCHLORIDE YILING Approval
03/18/2020 FENOFIBRATE
ANDA #211122		 ORIG-1 FENOFIBRATE GRAVITI PHARMS Approval
03/18/2020 TRIAMCINOLONE ACETONIDE
ANDA #211315		 ORIG-1 TRIAMCINOLONE ACETONIDE AUROBINDO PHARMA LTD Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065190		 SUPPL-5 CEFUROXIME AXETIL ANI PHARMS Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065190		 SUPPL-6 CEFUROXIME AXETIL ANI PHARMS Labeling Approval
03/19/2020 CLINDAMYCIN PHOSPHATE
ANDA #065254		 SUPPL-3 CLINDAMYCIN PHOSPHATE FOUGERA PHARMS Labeling Approval
03/19/2020 CLINDAMYCIN PHOSPHATE
ANDA #065254		 SUPPL-4 CLINDAMYCIN PHOSPHATE FOUGERA PHARMS Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065359		 SUPPL-7 CEFUROXIME AXETIL ANDA REPOSITORY Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065359		 SUPPL-8 CEFUROXIME AXETIL ANDA REPOSITORY Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065359		 SUPPL-9 CEFUROXIME AXETIL ANDA REPOSITORY Labeling Approval
03/19/2020 NAPROXEN
ANDA #074121		 SUPPL-22 NAPROXEN MYLAN Labeling Approval
03/19/2020 NAPROXEN
ANDA #074121		 SUPPL-23 NAPROXEN MYLAN Labeling Approval
03/19/2020 NAPROXEN
ANDA #074121		 SUPPL-24 NAPROXEN MYLAN Labeling Approval
03/19/2020 NAPROXEN SODIUM
ANDA #074367		 SUPPL-8 NAPROXEN SODIUM MYLAN Labeling Approval
03/19/2020 NAPROXEN SODIUM
ANDA #074367		 SUPPL-9 NAPROXEN SODIUM MYLAN Labeling Approval
03/19/2020 NAPROXEN SODIUM
ANDA #074367		 SUPPL-10 NAPROXEN SODIUM MYLAN Labeling Approval
03/19/2020 NAPROXEN
ANDA #075390		 SUPPL-5 NAPROXEN AUROBINDO PHARMA USA Labeling Approval
03/19/2020 NAPROXEN
ANDA #075390		 SUPPL-6 NAPROXEN AUROBINDO PHARMA USA Labeling Approval
03/19/2020 NAPROXEN
ANDA #075390		 SUPPL-7 NAPROXEN AUROBINDO PHARMA USA Labeling Approval
03/19/2020 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #076726		 SUPPL-9 ENOXAPARIN SODIUM ZYDUS PHARMS Labeling Approval
03/19/2020 PAROXETINE HYDROCHLORIDE
ANDA #077584		 SUPPL-28 PAROXETINE HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
03/19/2020 PAROXETINE HYDROCHLORIDE
ANDA #077584		 SUPPL-29 PAROXETINE HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
03/19/2020 PAROXETINE HYDROCHLORIDE
ANDA #078406		 SUPPL-25 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/19/2020 PAROXETINE HYDROCHLORIDE
ANDA #078406		 SUPPL-27 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
03/19/2020 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #078990		 SUPPL-3 ENOXAPARIN SODIUM GLAND Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #080408		 SUPPL-58 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #080408		 SUPPL-61 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE
ANDA #088294		 SUPPL-23 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE
ANDA #088294		 SUPPL-25 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #088299		 SUPPL-39 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #088299		 SUPPL-41 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #088325		 SUPPL-36 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #088325		 SUPPL-38 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #088327		 SUPPL-39 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #088327		 SUPPL-41 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE
ANDA #088328		 SUPPL-29 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE
ANDA #088328		 SUPPL-30 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE
ANDA #088329		 SUPPL-40 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 LIDOCAINE HYDROCHLORIDE
ANDA #088329		 SUPPL-41 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
03/19/2020 EPCLUSA
NDA #208341		 SUPPL-14 SOFOSBUVIR; VELPATASVIR GILEAD SCIENCES INC Efficacy Approval
03/19/2020 DAURISMO
NDA #210656		 SUPPL-2 GLASDEGIB MALEATE PFIZER Labeling Approval
03/19/2020 DAURISMO
NDA #210656		 SUPPL-4 GLASDEGIB MALEATE PFIZER Labeling Approval
03/19/2020 MESALAMINE
ANDA #213377		 ORIG-1 MESALAMINE ANNORA PHARMA Approval
03/19/2020 ONTRUZANT
BLA #761100		 SUPPL-5 TRASTUZUMAB-DTTB SAMSUNG BIOEPIS CO LTD Approval
03/20/2020 CREON
BLA #020725		 SUPPL-26 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) ABBVIE Approval
03/20/2020 RAZADYNE
NDA #021169		 SUPPL-34 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
03/20/2020 RAZADYNE ER
NDA #021615		 SUPPL-25 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
03/20/2020 PERTZYE
BLA #022175		 SUPPL-6 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) DIGESTIVE CARE INC Approval
03/20/2020 ZENPEP
BLA #022210		 SUPPL-21 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) EURAND PHARMA LTD Approval
03/20/2020 PANCREAZE
BLA #022523		 SUPPL-13 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIVUS INC Approval
03/20/2020 VIOKACE
BLA #022542		 SUPPL-5 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIOKACE Approval
03/20/2020 SEVOFLURANE
ANDA #075895		 SUPPL-12 SEVOFLURANE BAXTER HLTHCARE Labeling Approval
03/20/2020 BICALUTAMIDE
ANDA #076932		 SUPPL-7 BICALUTAMIDE TEVA Labeling Approval
03/20/2020 BICALUTAMIDE
ANDA #076932		 SUPPL-8 BICALUTAMIDE TEVA Labeling Approval
03/20/2020 BICALUTAMIDE
ANDA #079110		 SUPPL-3 BICALUTAMIDE SUN PHARM Labeling Approval
03/20/2020 BICALUTAMIDE
ANDA #079185		 SUPPL-5 BICALUTAMIDE RISING Labeling Approval
03/20/2020 BICALUTAMIDE
ANDA #079185		 SUPPL-6 BICALUTAMIDE RISING Labeling Approval
03/20/2020 BLINCYTO
BLA #125557		 SUPPL-17 BLINATUMOMAB AMGEN Approval
03/20/2020 VAZCULEP
NDA #204300		 SUPPL-11 PHENYLEPHRINE HYDROCHLORIDE EXELA PHARMA Labeling Approval
03/20/2020 OXYCODONE HYDROCHLORIDE
ANDA #207511		 SUPPL-7 OXYCODONE HYDROCHLORIDE WES PHARMA INC Manufacturing (CMC) Approval
03/20/2020 EPTIFIBATIDE
ANDA #207864		 ORIG-1 EPTIFIBATIDE HYBIO Approval
03/20/2020 PULMOTECH MAA
BLA #210089		 ORIG-1 TECHNETIUM TC99M ALBUMIN AGGREGATED CIS BIO INTL Approval
03/20/2020 CARFILZOMIB
ANDA #211185		 ORIG-1 CARFILZOMIB APOTEX Approval
03/20/2020 DAPAGLIFLOZIN
ANDA #211564		 ORIG-1 DAPAGLIFLOZIN GLENMARK GENERICS Tentative Approval
03/20/2020 PREGABALIN
ANDA #212865		 ORIG-1 PREGABALIN CHARTWELL RX Approval
03/20/2020 SKYRIZI
BLA #761105		 SUPPL-5 RISANKIZUMAB-RZAA ABBVIE INC Approval
03/23/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040657		 SUPPL-7 HYDROXYCHLOROQUINE SULFATE ZYDUS PHARMS USA INC Labeling Approval
03/23/2020 CLEOCIN
NDA #050680		 SUPPL-18 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
03/23/2020 CLEOCIN
NDA #050767		 SUPPL-17 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
03/23/2020 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077969		 SUPPL-7 HYDROCHLOROTHIAZIDE; IRBESARTAN MYLAN PHARMS INC Labeling Approval
03/23/2020 EUCRISA
NDA #207695		 SUPPL-7 CRISABOROLE ANACOR PHARMS INC Labeling Approval
03/23/2020 EUCRISA
NDA #207695		 SUPPL-9 CRISABOROLE ANACOR PHARMS INC Labeling Approval
03/23/2020 EUCRISA
NDA #207695		 SUPPL-10 CRISABOROLE ANACOR PHARMS INC Efficacy Approval
03/23/2020 PREVYMIS
NDA #209939		 SUPPL-8 LETERMOVIR MERCK SHARP DOHME Labeling Approval
03/23/2020 PREVYMIS
NDA #209940		 SUPPL-6 LETERMOVIR MERCK SHARP DOHME Labeling Approval
03/23/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #211751		 ORIG-1 ESOMEPRAZOLE MAGNESIUM CIPLA Approval
03/23/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #211752		 ORIG-1 ESOMEPRAZOLE MAGNESIUM CIPLA Approval
03/23/2020 RANOLAZINE
ANDA #211865		 ORIG-1 RANOLAZINE SUNSHINE Approval
03/23/2020 RANOLAZINE
ANDA #212781		 ORIG-1 RANOLAZINE PRAXGEN Approval
03/23/2020 PREGABALIN
ANDA #213423		 ORIG-1 PREGABALIN CREEKWOOD PHARMS Approval
03/24/2020 RELPAX
NDA #021016		 SUPPL-29 ELETRIPTAN HYDROBROMIDE UPJOHN Labeling Approval
03/24/2020 LACTULOSE
ANDA #074623		 SUPPL-10 LACTULOSE PHARM ASSOC Labeling Approval
03/24/2020 LACTULOSE
ANDA #074623		 SUPPL-11 LACTULOSE PHARM ASSOC Labeling Approval
03/24/2020 LACTULOSE
ANDA #074623		 SUPPL-12 LACTULOSE PHARM ASSOC Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-10 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-11 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-12 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-13 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #076999		 SUPPL-14 CLOPIDOGREL BISULFATE TEVA Labeling Approval
03/24/2020 CHLOROQUINE PHOSPHATE
ANDA #090249		 SUPPL-3 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
03/24/2020 CHLOROQUINE PHOSPHATE
ANDA #090249		 SUPPL-4 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #090307		 SUPPL-1 CLOPIDOGREL BISULFATE ACTAVIS TOTOWA Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #090307		 SUPPL-2 CLOPIDOGREL BISULFATE ACTAVIS TOTOWA Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #202266		 SUPPL-5 CLOPIDOGREL BISULFATE CHARTWELL RX Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #202266		 SUPPL-6 CLOPIDOGREL BISULFATE CHARTWELL RX Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #202266		 SUPPL-7 CLOPIDOGREL BISULFATE CHARTWELL RX Labeling Approval
03/24/2020 TIVICAY
NDA #204790		 SUPPL-23 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Labeling Approval
03/24/2020 TRIUMEQ
NDA #205551		 SUPPL-21 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #206376		 SUPPL-1 CLOPIDOGREL BISULFATE PRINSTON INC Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #206376		 SUPPL-2 CLOPIDOGREL BISULFATE PRINSTON INC Labeling Approval
03/24/2020 SERNIVO
NDA #208079		 SUPPL-2 BETAMETHASONE DIPROPIONATE PRIMUS PHARMS Labeling Approval
03/24/2020 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209754		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE BIONPHARMA Approval
03/24/2020 MILRINONE LACTATE
ANDA #211671		 ORIG-1 MILRINONE LACTATE MEITHEAL Approval
03/24/2020 DOVATO
NDA #211994		 SUPPL-4 DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Labeling Approval
03/24/2020 TIZANIDINE HYDROCHLORIDE
ANDA #213544		 ORIG-1 TIZANIDINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
03/25/2020 DATSCAN
NDA #022454		 SUPPL-7 IOFLUPANE I-123 GE HLTHCARE INC Labeling Approval
03/25/2020 LIDOCAINE HYDROCHLORIDE
ANDA #040433		 SUPPL-14 LIDOCAINE HYDROCHLORIDE SENTISS Labeling Approval
03/25/2020 SOJOURN
ANDA #077867		 SUPPL-18 SEVOFLURANE PIRAMAL CRITICAL Labeling Approval
03/25/2020 DORZOLAMIDE HYDROCHLORIDE
ANDA #078981		 SUPPL-5 DORZOLAMIDE HYDROCHLORIDE SANDOZ Labeling Approval
03/25/2020 DORZOLAMIDE HYDROCHLORIDE
ANDA #079186		 SUPPL-3 DORZOLAMIDE HYDROCHLORIDE AM REGENT Labeling Approval
03/25/2020 GABAPENTIN
ANDA #090858		 SUPPL-13 GABAPENTIN ALKEM Labeling Approval
03/25/2020 GABAPENTIN
ANDA #090858		 SUPPL-17 GABAPENTIN ALKEM Labeling Approval
03/25/2020 SUMATRIPTAN AND NAPROXEN SODIUM
ANDA #090872		 SUPPL-1 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE RISING Labeling Approval
03/25/2020 SAXENDA
NDA #206321		 SUPPL-11 LIRAGLUTIDE NOVO Efficacy Approval
03/25/2020 SEVELAMER CARBONATE
ANDA #207624		 SUPPL-1 SEVELAMER CARBONATE AUROBINDO PHARMA Labeling Approval
03/25/2020 ZEPOSIA
NDA #209899		 ORIG-1 OZANIMOD HYDROCHLORIDE BRISTOL Type 1 - New Molecular Entity Approval
03/25/2020 OMEPRAZOLE MAGNESIUM
ANDA #211732		 ORIG-1 OMEPRAZOLE MAGNESIUM HETERO LABS LTD III Approval
03/25/2020 GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #213203		 ORIG-1 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
03/25/2020 VERAPAMIL HYDROCHLORIDE
ANDA #213232		 ORIG-1 VERAPAMIL HYDROCHLORIDE CAPLIN Approval
03/26/2020 CARDIZEM CD
NDA #020062		 SUPPL-46 DILTIAZEM HYDROCHLORIDE BAUSCH Labeling Approval
03/26/2020 CHLOROQUINE PHOSPHATE
ANDA #090610		 SUPPL-4 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
03/26/2020 CHLOROQUINE PHOSPHATE
ANDA #090610		 SUPPL-5 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
03/26/2020 TALTZ
BLA #125521		 SUPPL-20 IXEKIZUMAB ELI LILLY AND CO Approval
03/27/2020 SEROQUEL
NDA #020639		 SUPPL-68 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
03/27/2020 SEROQUEL XR
NDA #022047		 SUPPL-42 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
03/27/2020 AVONEX
BLA #103628		 SUPPL-5263 INTERFERON BETA-1A BIOGEN Approval
03/27/2020 GAZYVA
BLA #125486		 SUPPL-25 OBINUTUZUMAB GENENTECH Approval
03/27/2020 PLEGRIDY
BLA #125499		 SUPPL-18 PEGINTERFERON BETA-1A BIOGEN IDEC INC Approval
03/27/2020 MOXIFLOXACIN HYDROCHLORIDE
NDA #205572		 SUPPL-7 MOXIFLOXACIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
03/27/2020 VERAPAMIL HYDROCHLORIDE
ANDA #206173		 SUPPL-3 VERAPAMIL HYDROCHLORIDE CADILA PHARMS LTD Labeling Approval
03/27/2020 AZATHIOPRINE
ANDA #208687		 ORIG-1 AZATHIOPRINE ALKEM LABS LTD Approval
03/27/2020 LEVOTHYROXINE SODIUM
ANDA #208837		 ORIG-1 LEVOTHYROXINE SODIUM DR REDDYS Approval
03/27/2020 TRIFERIC AVNU
NDA #212860		 ORIG-1 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Type 3 - New Dosage Form Approval
03/27/2020 BRINEURA
BLA #761052		 SUPPL-8 CERLIPONASE ALFA BIOMARIN PHARM Approval
03/27/2020 IMFINZI
BLA #761069		 SUPPL-18 DURVALUMAB ASTRAZENECA UK LTD Approval
03/30/2020 ALORA
NDA #020655		 SUPPL-19 ESTRADIOL ABBVIE Labeling Approval
03/30/2020 VERDESO
NDA #021978		 SUPPL-16 DESONIDE ALMIRALL Labeling Approval
03/30/2020 CARBOPLATIN
ANDA #077432		 SUPPL-8 CARBOPLATIN FRESENIUS KABI USA Labeling Approval
03/30/2020 TRADJENTA
NDA #201280		 SUPPL-20 LINAGLIPTIN BOEHRINGER INGELHEIM Efficacy Approval
03/30/2020 JENTADUETO
NDA #201281		 SUPPL-24 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
03/30/2020 BEKYREE
ANDA #202226		 SUPPL-4 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
03/30/2020 BEKYREE
ANDA #202226		 SUPPL-7 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
03/30/2020 ENTACAPONE
ANDA #202394		 SUPPL-2 ENTACAPONE MYLAN PHARMS INC Labeling Approval
03/30/2020 ENTACAPONE
ANDA #203437		 SUPPL-4 ENTACAPONE AUROBINDO PHARMA LTD Labeling Approval
03/30/2020 METOPROLOL SUCCINATE
ANDA #203699		 ORIG-1 METOPROLOL SUCCINATE PHARMADAX INC Approval
03/30/2020 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205601		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE RHODES PHARMS Approval
03/30/2020 GLYXAMBI
NDA #206073		 SUPPL-21 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Efficacy Approval
03/30/2020 MOXIFLOXACIN HYDROCHLORIDE
ANDA #206447		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE MYLAN Approval
03/30/2020 JENTADUETO XR
NDA #208026		 SUPPL-12 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
03/30/2020 ROFLUMILAST
ANDA #208247		 ORIG-1 ROFLUMILAST STRIDES PHARMA Approval
03/30/2020 VERZENIO
NDA #208716		 SUPPL-4 ABEMACICLIB ELI LILLY AND CO Efficacy Approval
03/30/2020 MOXIFLOXACIN HYDROCHLORIDE
ANDA #208778		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE GLAND PHARMA LTD Approval
03/30/2020 TYBLUME
NDA #209405		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL EXELTIS USA INC Type 3 - New Dosage Form Approval
03/30/2020 COLCHICINE
ANDA #209876		 SUPPL-1 COLCHICINE DR REDDYS Manufacturing (CMC) Approval
03/30/2020 DEFERASIROX
ANDA #210555		 ORIG-1 DEFERASIROX ALKEM LABS LTD Approval
03/30/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #211647		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Approval
03/31/2020 FERRLECIT
NDA #020955		 SUPPL-17 FERRIC OXYHYDROXIDE SANOFI AVENTIS US Labeling Approval
03/31/2020 HYDROXYCHLOROQUINE SULFATE
ANDA #040766		 SUPPL-13 HYDROXYCHLOROQUINE SULFATE IPCA LABS LTD Labeling Approval
03/31/2020 RIFAMPIN
ANDA #090034		 SUPPL-8 RIFAMPIN LUPIN PHARMS Labeling Approval
03/31/2020 RIFAMPIN
ANDA #090034		 SUPPL-9 RIFAMPIN LUPIN PHARMS Labeling Approval
03/31/2020 RIFAMPIN
ANDA #090034		 SUPPL-10 RIFAMPIN LUPIN PHARMS Labeling Approval
03/31/2020 RIFAMPIN
ANDA #090034		 SUPPL-11 RIFAMPIN LUPIN PHARMS Labeling Approval
03/31/2020 RIFAMPIN
ANDA #090034		 SUPPL-12 RIFAMPIN LUPIN PHARMS Labeling Approval
03/31/2020 ENTYVIO
BLA #125476		 SUPPL-25 VEDOLIZUMAB TAKEDA PHARMS USA Approval
03/31/2020 ENTYVIO
BLA #125476		 SUPPL-30 VEDOLIZUMAB TAKEDA PHARMS USA Approval
03/31/2020 METOPROLOL SUCCINATE
ANDA #203028		 ORIG-1 METOPROLOL SUCCINATE PHARMADAX INC Approval
03/31/2020 CINACALCET HYDROCHLORIDE
ANDA #203422		 SUPPL-1 CINACALCET HYDROCHLORIDE MYLAN Labeling Approval
03/31/2020 VORICONAZOLE
ANDA #211099		 ORIG-1 VORICONAZOLE GLAND PHARMA LTD Approval
03/31/2020 DOXYCYCLINE HYCLATE
ANDA #212610		 ORIG-1 DOXYCYCLINE HYCLATE ZHEJIANG YONGTAI Approval
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