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 October 20, 2020.

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 INC REMS Approval
03/02/2020 SUBOXONE
NDA #020733
SUPPL-27 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC 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 INC REMS Approval
03/02/2020 DORYX
NDA #050582
SUPPL-31 DOXYCYCLINE HYCLATE MAYNE PHARMA INTL 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 INC 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 NOVELGENIX THERAPS 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 MERCK SHARP DOHME Manufacturing (CMC) Approval
03/03/2020 CAPTOPRIL
ANDA #074434
SUPPL-16 CAPTOPRIL MYLAN 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 ANNORA PHARMA 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 PERRIGO PHARMS CO Labeling Approval
03/03/2020 CETIRIZINE HYDROCHLORIDE
ANDA #078488
SUPPL-6 CETIRIZINE HYDROCHLORIDE BRECKENRIDGE 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 LANNETT CO INC 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 CELLTRION 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 SAXAGLIPTIN HYDROCHLORIDE
ANDA #206078
ORIG-1 SAXAGLIPTIN HYDROCHLORIDE SUN PHARM INDS LTD Tentative Approval
03/03/2020 KHAPZORY
NDA #211226
SUPPL-2 LEVOLEUCOVORIN ACROTECH 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 USA INC Labeling Approval
03/04/2020 REMERON SOLTAB
NDA #021208
SUPPL-19 MIRTAZAPINE ORGANON USA INC Labeling Approval
03/04/2020 CLEOCIN PHOSPHATE
NDA #050441
SUPPL-83 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN Labeling Approval
03/04/2020 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639
SUPPL-41 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN 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 INC Labeling Approval
03/04/2020 ACTICLATE
NDA #205931
SUPPL-5 DOXYCYCLINE HYCLATE ALMIRALL 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 ALMIRALL 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 PHARMS LTD 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 PHARMS Approval
03/04/2020 DURYSTA
NDA #211911
ORIG-1 BIMATOPROST ALLERGAN INC 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 SENTYNL THERAPS INC 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 CIPLA LTD 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 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 ARBOR PHARMS LLC 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 PHARMACIA AND UPJOHN 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 INC Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079145
SUPPL-6 ROSUVASTATIN CALCIUM APOTEX INC 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 INC Labeling Approval
03/09/2020 ROSUVASTATIN CALCIUM
ANDA #079171
SUPPL-5 ROSUVASTATIN CALCIUM SANDOZ INC 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 ARBOR PHARMS LLC 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 BORTEZOMIB
ANDA #209659
ORIG-1 BORTEZOMIB FRESENIUS KABI USA Tentative 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 Type 4 - New Combination Approval
03/09/2020 TALZENNA
NDA #211651
SUPPL-5 TALAZOPARIB TOSYLATE PFIZER Efficacy Approval
03/09/2020 LURASIDONE HYDROCHLORIDE
ANDA #212244
ORIG-1 LURASIDONE HYDROCHLORIDE ALKEM LABS LTD Tentative 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 SANOFI AVENTIS 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 PHARMA Labeling Approval
03/10/2020 GEFITINIB
ANDA #209532
ORIG-1 GEFITINIB APOTEX INC Tentative Approval
03/10/2020 AMANTADINE HYDROCHLORIDE
ANDA #210215
ORIG-1 AMANTADINE HYDROCHLORIDE NOVELGENIX THERAPS 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 HIGH TECH PHARMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060
SUPPL-17 VALPROIC ACID HIGH TECH PHARMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060
SUPPL-18 VALPROIC ACID HIGH TECH PHARMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060
SUPPL-19 VALPROIC ACID HIGH TECH PHARMA Labeling Approval
03/11/2020 VALPROIC ACID
ANDA #074060
SUPPL-20 VALPROIC ACID HIGH TECH PHARMA Labeling Approval
03/11/2020 CAPTOPRIL
ANDA #074532
SUPPL-10 CAPTOPRIL WOCKHARDT LTD Labeling Approval
03/11/2020 CAPTOPRIL
ANDA #074532
SUPPL-12 CAPTOPRIL WOCKHARDT LTD 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 ROFLUMILAST
ANDA #208256
ORIG-1 ROFLUMILAST MSN LABORATORIES Tentative Approval
03/11/2020 CLINDAMYCIN PHOSPHATE
ANDA #210004
ORIG-1 CLINDAMYCIN PHOSPHATE TARO PHARM INDS LTD 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 LANNETT CO INC Labeling Approval
03/12/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #077471
SUPPL-13 HYDROMORPHONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
03/12/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #077471
SUPPL-16 HYDROMORPHONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
03/12/2020 ZONISAMIDE
ANDA #077625
SUPPL-7 ZONISAMIDE ZYDUS PHARMS USA 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 ENDO PHARMS INC 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 CADISTA PHARMS Labeling Approval
03/13/2020 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845
SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM CADISTA PHARMS Labeling Approval
03/13/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #203511
SUPPL-3 VALGANCICLOVIR HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
03/13/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #203511
SUPPL-4 VALGANCICLOVIR HYDROCHLORIDE DR REDDYS LABS LTD 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 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 MYLAN Labeling Approval
03/15/2020 MEMANTINE HYDROCHLORIDE
ANDA #206032
SUPPL-4 MEMANTINE HYDROCHLORIDE MYLAN 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 PADDOCK LLC 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 ORCHID HLTHCARE 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 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 LTD 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 OAKLOCK LLC 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 AKORN Labeling Approval
03/17/2020 OXAZEPAM
ANDA #071026
SUPPL-18 OXAZEPAM FRONTIDA BIOPHARM 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 AGIOS PHARMS INC Labeling Approval
03/17/2020 VERAPAMIL HYDROCHLORIDE
ANDA #213352
ORIG-1 VERAPAMIL HYDROCHLORIDE AREVA PHARMS 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 CELGENE 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 STRIDES PHARMA Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065190
SUPPL-5 CEFUROXIME AXETIL ANI PHARMS INC Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065190
SUPPL-6 CEFUROXIME AXETIL ANI PHARMS INC 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 ORCHID HLTHCARE Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065359
SUPPL-8 CEFUROXIME AXETIL ORCHID HLTHCARE Labeling Approval
03/19/2020 CEFUROXIME AXETIL
ANDA #065359
SUPPL-9 CEFUROXIME AXETIL ORCHID HLTHCARE 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 MYLAN PHARMS INC Labeling Approval
03/19/2020 NAPROXEN
ANDA #075390
SUPPL-6 NAPROXEN MYLAN PHARMS INC Labeling Approval
03/19/2020 NAPROXEN
ANDA #075390
SUPPL-7 NAPROXEN MYLAN PHARMS INC Labeling Approval
03/19/2020 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #076726
SUPPL-9 ENOXAPARIN SODIUM TEVA 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 APOTEX INC 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
03/20/2020 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) ZENPEP 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 MYLAN Labeling Approval
03/20/2020 BICALUTAMIDE
ANDA #079185
SUPPL-6 BICALUTAMIDE MYLAN 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 EYWA 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 PIRFENIDONE
ANDA #212569
ORIG-1 PIRFENIDONE AMNEAL Tentative Approval
03/20/2020 PREGABALIN
ANDA #212865
ORIG-1 PREGABALIN CELLTRION Approval
03/20/2020 BORTEZOMIB
ANDA #212958
ORIG-1 BORTEZOMIB HONG KONG KING FRIEND INDUSTRIAL CO LTD Tentative 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 PHARMACIA AND UPJOHN Labeling Approval
03/23/2020 CLEOCIN
NDA #050767
SUPPL-17 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN 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 SUNGEN PHARMA Approval
03/23/2020 PREGABALIN
ANDA #213423
ORIG-1 PREGABALIN HIKAL 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 CELLTRION Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #202266
SUPPL-6 CLOPIDOGREL BISULFATE CELLTRION Labeling Approval
03/24/2020 CLOPIDOGREL BISULFATE
ANDA #202266
SUPPL-7 CLOPIDOGREL BISULFATE CELLTRION 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 ENCORE DERMAT Labeling Approval
03/24/2020 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209754
ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE BIONPHARMA INC 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 AKORN 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 INC 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 MYLAN Labeling Approval
03/25/2020 SAXENDA
NDA #206321
SUPPL-11 LIRAGLUTIDE RECOMBINANT NOVO Efficacy Approval
03/25/2020 SEVELAMER CARBONATE
ANDA #207624
SUPPL-1 SEVELAMER CARBONATE AUROBINDO PHARMA LTD Labeling Approval
03/25/2020 ZEPOSIA
NDA #209899
ORIG-1 OZANIMOD HYDROCHLORIDE CELGENE INTL 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 PREGABALIN
ANDA #211889
ORIG-1 PREGABALIN SUN PHARM INDS LTD Tentative 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 PHARMS 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 COLCHICINE
ANDA #212880
ORIG-1 COLCHICINE MICRO LABS LTD Tentative 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 ALLERGAN 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 SODIUM FERRIC GLUCONATE COMPLEX 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 CARFILZOMIB
ANDA #210823
ORIG-1 CARFILZOMIB EUGIA PHARMA Tentative 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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