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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 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 June 15, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2020 ROWASA
NDA #019618		 SUPPL-26 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
10/01/2020 SFROWASA
NDA #019618		 SUPPL-26 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
10/01/2020 ASACOL
NDA #019651		 SUPPL-28 MESALAMINE APIL Labeling Approval
10/01/2020 PENTASA
NDA #020049		 SUPPL-33 MESALAMINE TAKEDA PHARMS USA Labeling Approval
10/01/2020 COLAZAL
NDA #020610		 SUPPL-23 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
10/01/2020 CANASA
NDA #021252		 SUPPL-25 MESALAMINE ABBVIE Labeling Approval
10/01/2020 CYMBALTA
NDA #021427		 SUPPL-53 DULOXETINE HYDROCHLORIDE LILLY Labeling Approval
10/01/2020 ASACOL HD
NDA #021830		 SUPPL-16 MESALAMINE ABBVIE Labeling Approval
10/01/2020 LIALDA
NDA #022000		 SUPPL-20 MESALAMINE TAKEDA PHARMS USA Labeling Approval
10/01/2020 GIAZO
NDA #022205		 SUPPL-4 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
10/01/2020 APRISO
NDA #022301		 SUPPL-15 MESALAMINE SALIX Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078235		 SUPPL-20 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078235		 SUPPL-21 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078235		 SUPPL-23 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078235		 SUPPL-24 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078235		 SUPPL-25 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078235		 SUPPL-29 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078877		 SUPPL-12 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078877		 SUPPL-13 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078877		 SUPPL-15 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078877		 SUPPL-16 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078877		 SUPPL-17 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 TOPIRAMATE
ANDA #078877		 SUPPL-20 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
10/01/2020 ALFUZOSIN HYDROCHLORIDE
ANDA #079057		 SUPPL-18 ALFUZOSIN HYDROCHLORIDE SUN PHARM Labeling Approval
10/01/2020 BETASERON
BLA #103471		 SUPPL-5197 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
10/01/2020 DEXLANSOPRAZOLE
ANDA #202294		 SUPPL-1 DEXLANSOPRAZOLE ENDO OPERATIONS Labeling Approval
10/01/2020 DELZICOL
NDA #204412		 SUPPL-12 MESALAMINE ABBVIE Labeling Approval
10/01/2020 ACETAZOLAMIDE
ANDA #207401		 ORIG-1 ACETAZOLAMIDE MICRO LABS LTD INDIA Approval
10/01/2020 MIDODRINE HYDROCHLORIDE
ANDA #207849		 ORIG-1 MIDODRINE HYDROCHLORIDE XIROMED Approval
10/02/2020 SABRIL
NDA #020427		 SUPPL-24 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
10/02/2020 SABRIL
NDA #022006		 SUPPL-25 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
10/02/2020 AZOR
NDA #022100		 SUPPL-39 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
10/02/2020 GALANTAMINE HYDROBROMIDE
ANDA #078898		 SUPPL-9 GALANTAMINE HYDROBROMIDE ZYDUS PHARMS USA INC Labeling Approval
10/02/2020 LORAZEPAM
ANDA #091383		 SUPPL-2 LORAZEPAM AMNEAL PHARMS Labeling Approval
10/02/2020 LORAZEPAM
ANDA #091383		 SUPPL-4 LORAZEPAM AMNEAL PHARMS Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091576		 SUPPL-18 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091576		 SUPPL-20 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091588		 SUPPL-17 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
10/02/2020 MONTELUKAST SODIUM
ANDA #091588		 SUPPL-19 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
10/02/2020 YERVOY
BLA #125377		 SUPPL-115 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
10/02/2020 KEYTRUDA
BLA #125514		 SUPPL-70 PEMBROLIZUMAB MERCK SHARP DOHME Approval
10/02/2020 OPDIVO
BLA #125554		 SUPPL-89 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
10/02/2020 TRIBENZOR
NDA #200175		 SUPPL-33 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
10/02/2020 ZYTIGA
NDA #202379		 SUPPL-31 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
10/02/2020 ZYTIGA
NDA #202379		 SUPPL-33 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
10/02/2020 GATIFLOXACIN
ANDA #202653		 SUPPL-7 GATIFLOXACIN LUPIN LTD Labeling Approval
10/02/2020 GATIFLOXACIN
ANDA #203189		 SUPPL-1 GATIFLOXACIN HIKMA Labeling Approval
10/02/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #203893		 SUPPL-14 OMEGA-3-ACID ETHYL ESTERS STRIDES PHARMA Manufacturing (CMC) Approval
10/02/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #203893		 SUPPL-15 OMEGA-3-ACID ETHYL ESTERS STRIDES PHARMA Labeling Approval
10/02/2020 GABAPENTIN
ANDA #207099		 SUPPL-1 GABAPENTIN GRAVITI PHARMS Labeling Approval
10/02/2020 GABAPENTIN
ANDA #207099		 SUPPL-2 GABAPENTIN GRAVITI PHARMS Labeling Approval
10/02/2020 VIGABATRIN
ANDA #208218		 SUPPL-11 VIGABATRIN ENDO OPERATIONS REMS Approval
10/02/2020 VIGABATRIN
ANDA #209822		 SUPPL-8 VIGABATRIN TEVA PHARMS USA REMS Approval
10/02/2020 VIGABATRIN
ANDA #209824		 SUPPL-9 VIGABATRIN TEVA PHARMS USA REMS Approval
10/02/2020 VIGABATRIN
ANDA #210155		 SUPPL-10 VIGABATRIN AMNEAL PHARMS REMS Approval
10/02/2020 VIGADRONE
ANDA #210196		 SUPPL-7 VIGABATRIN AUCTA REMS Approval
10/02/2020 VIGABATRIN
ANDA #211481		 SUPPL-6 VIGABATRIN DR REDDYS REMS Approval
10/02/2020 VIGABATRIN
ANDA #211592		 SUPPL-4 VIGABATRIN INVAGEN PHARMS REMS Approval
10/02/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #212949		 ORIG-1 ESOMEPRAZOLE MAGNESIUM CSPC OUYI Approval
10/02/2020 LAMPIT
NDA #213464		 SUPPL-1 NIFURTIMOX BAYER HEALTHCARE Labeling Approval
10/02/2020 VIGABATRIN
ANDA #213469		 SUPPL-1 VIGABATRIN GRANULES REMS Approval
10/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #213897		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE AJANTA PHARMA LTD Approval
10/03/2020 EPHEDRINE SULFATE
ANDA #212649		 ORIG-1 EPHEDRINE SULFATE DR REDDYS Approval
10/05/2020 ERAXIS
NDA #021632		 SUPPL-30 ANIDULAFUNGIN VICURON HOLDINGS Labeling Approval
10/05/2020 MONTELUKAST SODIUM
ANDA #090984		 SUPPL-11 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
10/05/2020 MONTELUKAST SODIUM
ANDA #090984		 SUPPL-13 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
10/05/2020 TYSABRI
BLA #125104		 SUPPL-971 NATALIZUMAB BIOGEN IDEC Approval
10/05/2020 MONTELUKAST SODIUM
ANDA #201515		 SUPPL-13 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
10/05/2020 MONTELUKAST SODIUM
ANDA #201515		 SUPPL-16 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
10/05/2020 DOXYCYCLINE HYCLATE
ANDA #209987		 ORIG-1 DOXYCYCLINE HYCLATE RISING Approval
10/05/2020 ATROPINE SULFATE
ANDA #212461		 ORIG-1 ATROPINE SULFATE INTL MEDICATION SYS Approval
10/05/2020 ICATIBANT ACETATE
ANDA #213054		 ORIG-1 ICATIBANT ACETATE DR REDDYS Approval
10/06/2020 PHENYTOIN SODIUM
ANDA #040573		 SUPPL-12 PHENYTOIN SODIUM ACELLA Labeling Approval
10/06/2020 GEMCITABINE HYDROCHLORIDE
ANDA #090799		 SUPPL-14 GEMCITABINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/06/2020 GEMCITABINE HYDROCHLORIDE
ANDA #090799		 SUPPL-15 GEMCITABINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/06/2020 RIZATRIPTAN BENZOATE
ANDA #202490		 SUPPL-8 RIZATRIPTAN BENZOATE AUROBINDO PHARMA LTD Labeling Approval
10/06/2020 DIMETHYL FUMARATE
ANDA #210226		 ORIG-1 DIMETHYL FUMARATE LUPIN Approval
10/06/2020 DIMETHYL FUMARATE
ANDA #210309		 ORIG-1 DIMETHYL FUMARATE GLENMARK PHARMS LTD Approval
10/06/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #212288		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Approval
10/06/2020 FOSFOMYCIN TROMETHAMINE
ANDA #212548		 ORIG-1 FOSFOMYCIN TROMETHAMINE XIROMED Approval
10/06/2020 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #213335		 ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE SPECGX LLC Approval
10/06/2020 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
NDA #213556		 ORIG-1 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD Type 4 - New Combination Tentative Approval
10/06/2020 HALOBETASOL PROPIONATE
ANDA #213560		 ORIG-1 HALOBETASOL PROPIONATE QUAGEN Approval
10/06/2020 PALYNZIQ
BLA #761079		 SUPPL-5 PEGVALIASE-PQPZ BIOMARIN PHARM Approval
10/06/2020 PALYNZIQ
BLA #761079		 SUPPL-6 PEGVALIASE-PQPZ BIOMARIN PHARM Approval
10/06/2020 PALYNZIQ
BLA #761079		 SUPPL-7 PEGVALIASE-PQPZ BIOMARIN PHARM Approval
10/07/2020 DIPENTUM
NDA #019715		 SUPPL-28 OLSALAZINE SODIUM MYLAN SPCLT VIATRIS Labeling Approval
10/07/2020 DIGOXIN
ANDA #076363		 SUPPL-19 DIGOXIN SUN PHARM INDS INC Labeling Approval
10/07/2020 DIGOXIN
ANDA #076363		 SUPPL-22 DIGOXIN SUN PHARM INDS INC Labeling Approval
10/07/2020 DIGOXIN
ANDA #076363		 SUPPL-25 DIGOXIN SUN PHARM INDS INC Labeling Approval
10/07/2020 DIGOXIN
ANDA #076363		 SUPPL-26 DIGOXIN SUN PHARM INDS INC Labeling Approval
10/07/2020 DIGOXIN
ANDA #076363		 SUPPL-30 DIGOXIN SUN PHARM INDS INC Labeling Approval
10/07/2020 DIGOXIN
ANDA #076363		 SUPPL-32 DIGOXIN SUN PHARM INDS INC Labeling Approval
10/07/2020 DIGOXIN
ANDA #077002		 SUPPL-15 DIGOXIN HIKMA INTL PHARMS Labeling Approval
10/07/2020 DIGOXIN
ANDA #077002		 SUPPL-20 DIGOXIN HIKMA INTL PHARMS Labeling Approval
10/07/2020 DIGOXIN
ANDA #077002		 SUPPL-22 DIGOXIN HIKMA INTL PHARMS Labeling Approval
10/07/2020 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-35 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
10/07/2020 LANSOPRAZOLE
ANDA #202194		 SUPPL-6 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
10/07/2020 LANSOPRAZOLE
ANDA #202194		 SUPPL-7 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
10/07/2020 LANSOPRAZOLE
ANDA #202194		 SUPPL-8 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
10/07/2020 CINACALCET HYDROCHLORIDE
ANDA #209403		 ORIG-1 CINACALCET HYDROCHLORIDE HETERO LABS LTD V Approval
10/07/2020 AZELAIC ACID
ANDA #210928		 ORIG-1 AZELAIC ACID TEVA PHARMS USA Approval
10/07/2020 ACETAZOLAMIDE
ANDA #214282		 ORIG-1 ACETAZOLAMIDE MANKIND PHARMA Approval
10/08/2020 ACTIVASE
BLA #103172		 SUPPL-5267 ALTEPLASE GENENTECH Approval
10/08/2020 CATHFLO ACTIVASE
BLA #103172		 SUPPL-5267 ALTEPLASE GENENTECH Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #200405		 SUPPL-10 MONTELUKAST SODIUM LANNETT CO INC Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #200405		 SUPPL-12 MONTELUKAST SODIUM LANNETT CO INC Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #200405		 SUPPL-14 MONTELUKAST SODIUM LANNETT CO INC Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #201522		 SUPPL-10 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #201522		 SUPPL-12 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
10/08/2020 MONTELUKAST SODIUM
ANDA #201522		 SUPPL-14 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
10/08/2020 INJECTAFER
NDA #203565		 SUPPL-12 FERRIC CARBOXYMALTOSE AM REGENT Manufacturing (CMC) Approval
10/08/2020 PROMACTA KIT
NDA #207027		 SUPPL-13 ELTROMBOPAG OLAMINE NOVARTIS Manufacturing (CMC) Approval
10/08/2020 LANSOPRAZOLE
ANDA #207157		 SUPPL-1 LANSOPRAZOLE LANNETT CO INC Labeling Approval
10/08/2020 LANSOPRAZOLE
ANDA #207157		 SUPPL-2 LANSOPRAZOLE LANNETT CO INC Labeling Approval
10/08/2020 RUBRACA
NDA #209115		 SUPPL-8 RUCAPARIB CAMSYLATE ZR PHARMA Efficacy Approval
10/08/2020 XENLETA
NDA #211672		 SUPPL-1 LEFAMULIN ACETATE NABRIVA Labeling Approval
10/08/2020 XENLETA
NDA #211673		 SUPPL-1 LEFAMULIN ACETATE NABRIVA Labeling Approval
10/08/2020 ALBUTEROL SULFATE
ANDA #213524		 ORIG-1 ALBUTEROL SULFATE EYWA Approval
10/08/2020 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #214238		 ORIG-1 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE QUAGEN Approval
10/09/2020 LAMICTAL
NDA #020241		 SUPPL-58 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
10/09/2020 LAMICTAL CD
NDA #020764		 SUPPL-51 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
10/09/2020 TINDAMAX
NDA #021618		 SUPPL-7 TINIDAZOLE MISSION PHARMA Labeling Approval
10/09/2020 LAMICTAL XR
NDA #022115		 SUPPL-24 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
10/09/2020 LAMICTAL ODT
NDA #022251		 SUPPL-22 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
10/09/2020 UNASYN
NDA #050608		 SUPPL-47 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
10/09/2020 AVASTIN
BLA #125085		 SUPPL-336 BEVACIZUMAB GENENTECH Approval
10/09/2020 FOLIC ACID
ANDA #202437		 SUPPL-2 FOLIC ACID CADILA PHARMS LTD Labeling Approval
10/09/2020 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #207033		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL NAARI PTE LTD Approval
10/09/2020 BACLOFEN
ANDA #212378		 ORIG-1 BACLOFEN INNOGENIX Approval
10/09/2020 ULTOMIRIS
BLA #761108		 SUPPL-5 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
10/13/2020 FENOFIBRATE
ANDA #076635		 SUPPL-10 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
10/13/2020 FENOFIBRATE
ANDA #076635		 SUPPL-11 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
10/13/2020 FENOFIBRATE
ANDA #076635		 SUPPL-13 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
10/13/2020 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-17 DIVALPROEX SODIUM TEVA Labeling Approval
10/13/2020 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-19 DIVALPROEX SODIUM TEVA Labeling Approval
10/13/2020 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-20 DIVALPROEX SODIUM TEVA Labeling Approval
10/13/2020 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-21 DIVALPROEX SODIUM TEVA Labeling Approval
10/13/2020 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-23 DIVALPROEX SODIUM TEVA Labeling Approval
10/13/2020 DIVALPROEX SODIUM
ANDA #076941		 SUPPL-25 DIVALPROEX SODIUM TEVA Labeling Approval
10/13/2020 RISPERIDONE
ANDA #077769		 SUPPL-3 RISPERIDONE HERITAGE PHARMA AVET Labeling Approval
10/13/2020 RISPERIDONE
ANDA #077769		 SUPPL-4 RISPERIDONE HERITAGE PHARMA AVET Labeling Approval
10/13/2020 LEUCOVORIN CALCIUM
ANDA #089384		 SUPPL-31 LEUCOVORIN CALCIUM HIKMA Labeling Approval
10/13/2020 DOXERCALCIFEROL
ANDA #091433		 SUPPL-7 DOXERCALCIFEROL HIKMA Labeling Approval
10/13/2020 ATORVASTATIN CALCIUM
ANDA #091650		 SUPPL-16 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
10/13/2020 ATORVASTATIN CALCIUM
ANDA #091650		 SUPPL-17 ATORVASTATIN CALCIUM DR REDDYS LABS LTD Labeling Approval
10/13/2020 CYTARABINE
ANDA #200914		 SUPPL-8 CYTARABINE RISING Labeling Approval
10/13/2020 CYTARABINE
ANDA #200915		 SUPPL-5 CYTARABINE RISING Labeling Approval
10/13/2020 GLIMEPIRIDE
ANDA #202112		 SUPPL-7 GLIMEPIRIDE INDOCO REMEDIES Labeling Approval
10/13/2020 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #202239		 SUPPL-14 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
10/13/2020 BINOSTO
NDA #202344		 SUPPL-15 ALENDRONATE SODIUM RADIUS Labeling Approval
10/13/2020 REMIFENTANIL HYDROCHLORIDE
ANDA #210594		 ORIG-1 REMIFENTANIL HYDROCHLORIDE HIKMA Approval
10/13/2020 WAKIX
NDA #211150		 ORIG-2 PITOLISANT HYDROCHLORIDE HARMONY Efficacy Approval
10/13/2020 TAVABOROLE
ANDA #211297		 ORIG-1 TAVABOROLE ENCUBE Approval
10/13/2020 TAVABOROLE
ANDA #211848		 ORIG-1 TAVABOROLE PADAGIS US Approval
10/14/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-7 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ISTITUTO BIO ITA SPA Labeling Approval
10/14/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-19 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ISTITUTO BIO ITA SPA Labeling Approval
10/14/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-21 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ISTITUTO BIO ITA SPA Labeling Approval
10/14/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-22 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ISTITUTO BIO ITA SPA Labeling Approval
10/14/2020 VALPROIC ACID
ANDA #077960		 SUPPL-20 VALPROIC ACID LANNETT CO INC Labeling Approval
10/14/2020 VALPROIC ACID
ANDA #077960		 SUPPL-21 VALPROIC ACID LANNETT CO INC Labeling Approval
10/14/2020 VALPROIC ACID
ANDA #077960		 SUPPL-22 VALPROIC ACID LANNETT CO INC Labeling Approval
10/14/2020 VALPROIC ACID
ANDA #077960		 SUPPL-24 VALPROIC ACID LANNETT CO INC Labeling Approval
10/14/2020 VALPROIC ACID
ANDA #077960		 SUPPL-26 VALPROIC ACID LANNETT CO INC Labeling Approval
10/14/2020 KEYTRUDA
BLA #125514		 SUPPL-85 PEMBROLIZUMAB MERCK SHARP DOHME Approval
10/14/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203354		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE DR REDDYS Labeling Approval
10/14/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203354		 SUPPL-5 PRAMIPEXOLE DIHYDROCHLORIDE DR REDDYS Labeling Approval
10/14/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203354		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE DR REDDYS Labeling Approval
10/14/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #207994		 ORIG-1 FINGOLIMOD HYDROCHLORIDE ZYDUS PHARMS Approval
10/14/2020 DIMETHYL FUMARATE
ANDA #210382		 ORIG-1 DIMETHYL FUMARATE TWI PHARMS Approval
10/14/2020 INMAZEB
BLA #761169		 ORIG-1 ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB REGENERON PHARMACEUTICALS Approval
10/15/2020 CARDIOGEN-82
NDA #019414		 SUPPL-21 RUBIDIUM CHLORIDE RB-82 BRACCO Efficacy Approval
10/15/2020 LUMIGAN
NDA #021275		 SUPPL-28 BIMATOPROST ABBVIE Labeling Approval
10/15/2020 PEGASYS
BLA #103964		 SUPPL-5273 PEGINTERFERON ALFA-2A zr pharma& Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963		 SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #201963		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202891		 SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS Labeling Approval
10/15/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202891		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS Labeling Approval
10/15/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #210025		 SUPPL-6 PHENYLEPHRINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/15/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #210231		 SUPPL-4 SUCCINYLCHOLINE CHLORIDE AMRING PHARMS Labeling Approval
10/15/2020 VERAPAMIL HYDROCHLORIDE
ANDA #214215		 ORIG-1 VERAPAMIL HYDROCHLORIDE ZYDUS PHARMS Approval
10/15/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #214246		 SUPPL-1 SUCCINYLCHOLINE CHLORIDE GLAND PHARMA LTD Labeling Approval
10/15/2020 AMANTADINE HYDROCHLORIDE
ANDA #214284		 ORIG-1 AMANTADINE HYDROCHLORIDE ALEMBIC Approval
10/15/2020 VERAPAMIL HYDROCHLORIDE
ANDA #214361		 ORIG-1 VERAPAMIL HYDROCHLORIDE GLAND PHARMA LTD Approval
10/16/2020 BUPROPION HYDROCHLORIDE
ANDA #077715		 SUPPL-34 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
10/16/2020 BUPROPION HYDROCHLORIDE
ANDA #077715		 SUPPL-38 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
10/16/2020 RASAGILINE MESYLATE
ANDA #201970		 SUPPL-5 RASAGILINE MESYLATE ORBION PHARMS Labeling Approval
10/16/2020 MIRTAZAPINE
ANDA #205798		 SUPPL-1 MIRTAZAPINE SQUARE PHARMS Labeling Approval
10/16/2020 RASAGILINE MESYLATE
ANDA #207004		 SUPPL-2 RASAGILINE MESYLATE MICRO LABS Labeling Approval
10/16/2020 ENSTILAR
NDA #207589		 SUPPL-10 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Efficacy Approval
10/16/2020 VENCLEXTA
NDA #208573		 SUPPL-20 VENETOCLAX ABBVIE Efficacy Approval
10/16/2020 VENCLEXTA
NDA #208573		 SUPPL-21 VENETOCLAX ABBVIE Efficacy Approval
10/16/2020 SIROLIMUS
ANDA #208691		 ORIG-1 SIROLIMUS GLENMARK PHARMS LTD Approval
10/16/2020 DOXEPIN HYDROCHLORIDE
ANDA #210675		 ORIG-1 DOXEPIN HYDROCHLORIDE EPIC PHARMA LLC Approval
10/16/2020 EPHEDRINE SULFATE
NDA #213994		 ORIG-1 EPHEDRINE SULFATE ENDO OPERATIONS Type 5 - New Formulation or New Manufacturer Approval
10/16/2020 URSODIOL
ANDA #214295		 ORIG-1 URSODIOL ZYDUS LIFESCIENCES Approval
10/18/2020 AZITHROMYCIN
ANDA #209201		 SUPPL-3 AZITHROMYCIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 QSYMIA
NDA #022580		 SUPPL-17 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Labeling Approval
10/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065401		 SUPPL-12 VANCOMYCIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
10/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065401		 SUPPL-14 VANCOMYCIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
10/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065401		 SUPPL-15 VANCOMYCIN HYDROCHLORIDE PHARM ASSOC Labeling Approval
10/19/2020 CISPLATIN
ANDA #074735		 SUPPL-13 CISPLATIN FRESENIUS KABI USA Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080		 SUPPL-1 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080		 SUPPL-2 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080		 SUPPL-3 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080		 SUPPL-4 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 DIVALPROEX SODIUM
ANDA #079080		 SUPPL-5 DIVALPROEX SODIUM ACTAVIS LABS FL INC Labeling Approval
10/19/2020 NARATRIPTAN
ANDA #091326		 SUPPL-4 NARATRIPTAN HYDROCHLORIDE PADAGIS US Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384		 SUPPL-5 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384		 SUPPL-6 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384		 SUPPL-7 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384		 SUPPL-8 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 RISPERIDONE
ANDA #091384		 SUPPL-9 RISPERIDONE AMNEAL PHARMS Labeling Approval
10/19/2020 TRANEXAMIC ACID
ANDA #091657		 SUPPL-9 TRANEXAMIC ACID MYLAN INSTITUTIONAL Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651		 SUPPL-8 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651		 SUPPL-9 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651		 SUPPL-11 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651		 SUPPL-12 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 GABAPENTIN
ANDA #200651		 SUPPL-20 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 CYTARABINE
ANDA #200916		 SUPPL-5 CYTARABINE MYLAN LABS LTD Labeling Approval
10/19/2020 LEVOFLOXACIN
ANDA #201043		 SUPPL-21 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 LEVOFLOXACIN
ANDA #201043		 SUPPL-22 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 LEVOFLOXACIN
ANDA #201043		 SUPPL-28 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/19/2020 TRANEXAMIC ACID
ANDA #201580		 SUPPL-4 TRANEXAMIC ACID XGEN PHARMS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-12 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-13 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-16 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202206		 SUPPL-18 PRAMIPEXOLE DIHYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/19/2020 ZOLEDRONIC ACID
ANDA #202650		 SUPPL-10 ZOLEDRONIC ACID MYLAN LABS LTD Labeling Approval
10/19/2020 OXYCODONE HYDROCHLORIDE
ANDA #203208		 SUPPL-3 OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2020 OXYCODONE HYDROCHLORIDE
ANDA #203208		 SUPPL-5 OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2020 OXYCODONE HYDROCHLORIDE
ANDA #203208		 SUPPL-7 OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/19/2020 JYNARQUE
NDA #204441		 SUPPL-8 TOLVAPTAN OTSUKA Labeling Approval
10/19/2020 ZYDELIG
NDA #205858		 SUPPL-14 IDELALISIB GILEAD SCIENCES INC Labeling Approval
10/19/2020 ARIKAYCE KIT
NDA #207356		 SUPPL-3 AMIKACIN SULFATE INSMED INC Efficacy Approval
10/19/2020 SOLIFENACIN SUCCINATE
ANDA #207721		 ORIG-1 SOLIFENACIN SUCCINATE ZYDUS PHARMS Approval
10/19/2020 LEVOTHYROXINE SODIUM
ANDA #212399		 ORIG-1 LEVOTHYROXINE SODIUM ACCORD HLTHCARE Approval
10/19/2020 ETHACRYNIC ACID
ANDA #213240		 ORIG-1 ETHACRYNIC ACID CHARTWELL RX Approval
10/19/2020 FENOFIBRATE (MICRONIZED)
ANDA #213842		 ORIG-1 FENOFIBRATE ALEMBIC Approval
10/19/2020 IBUPROFEN
ANDA #214003		 ORIG-1 IBUPROFEN YICHANG HUMANWELL Approval
10/20/2020 WELLBUTRIN
NDA #018644		 SUPPL-57 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
10/20/2020 WELLBUTRIN SR
NDA #020358		 SUPPL-64 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
10/20/2020 SABRIL
NDA #020427		 SUPPL-23 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/20/2020 TRISENOX
NDA #021248		 SUPPL-19 ARSENIC TRIOXIDE CEPHALON Labeling Approval
10/20/2020 FOLOTYN
NDA #022468		 SUPPL-14 PRALATREXATE ACROTECH BIOPHARMA Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542		 SUPPL-5 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542		 SUPPL-6 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542		 SUPPL-7 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #077542		 SUPPL-8 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474		 SUPPL-5 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474		 SUPPL-6 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474		 SUPPL-7 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 RISPERIDONE
ANDA #078474		 SUPPL-8 RISPERIDONE SUN PHARM INDS LTD Labeling Approval
10/20/2020 METHOTREXATE SODIUM
ANDA #081099		 SUPPL-39 METHOTREXATE SODIUM BARR Labeling Approval
10/20/2020 METHOTREXATE SODIUM
ANDA #081099		 SUPPL-41 METHOTREXATE SODIUM BARR Labeling Approval
10/20/2020 METHOTREXATE SODIUM
ANDA #081099		 SUPPL-45 METHOTREXATE SODIUM BARR Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509		 SUPPL-8 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509		 SUPPL-10 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509		 SUPPL-11 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #091509		 SUPPL-19 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 ZOLEDRONIC ACID
ANDA #202182		 SUPPL-2 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
10/20/2020 ZOLEDRONIC ACID
ANDA #202182		 SUPPL-3 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
10/20/2020 ZOLEDRONIC ACID
ANDA #202182		 SUPPL-4 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
10/20/2020 NARATRIPTAN
ANDA #202431		 SUPPL-3 NARATRIPTAN HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637		 SUPPL-6 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637		 SUPPL-8 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637		 SUPPL-9 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 LANSOPRAZOLE
ANDA #202637		 SUPPL-15 LANSOPRAZOLE SUN PHARM Labeling Approval
10/20/2020 MONTELUKAST SODIUM
ANDA #203328		 SUPPL-10 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
10/20/2020 MONTELUKAST SODIUM
ANDA #203432		 SUPPL-10 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
10/20/2020 MONTELUKAST SODIUM
ANDA #203438		 SUPPL-16 MONTELUKAST SODIUM AJANTA PHARMA LTD Labeling Approval
10/20/2020 NUZYRA
NDA #209816		 SUPPL-9 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
10/20/2020 NUZYRA
NDA #209817		 SUPPL-8 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Labeling Approval
10/20/2020 KETOROLAC TROMETHAMINE
ANDA #212939		 ORIG-1 KETOROLAC TROMETHAMINE EUGIA PHARMA Approval
10/20/2020 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #213530		 ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CHARTWELL RX Approval
10/20/2020 TRIAZOLAM
ANDA #214219		 ORIG-1 TRIAZOLAM NOVAST LABS Approval
10/20/2020 ESOMEPRAZOLE MAGNESIUM
NDA #214278		 ORIG-1 ESOMEPRAZOLE MAGNESIUM DEXCEL Type 3 - New Dosage Form Approval
10/21/2020 LEVOPHED
NDA #007513		 SUPPL-45 NOREPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
10/21/2020 NORVIR
NDA #020659		 SUPPL-72 RITONAVIR ABBVIE Labeling Approval
10/21/2020 NORVIR
NDA #020945		 SUPPL-48 RITONAVIR ABBVIE Labeling Approval
10/21/2020 KALETRA
NDA #021226		 SUPPL-49 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/21/2020 KALETRA
NDA #021251		 SUPPL-59 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/21/2020 VALCYTE
NDA #021304		 SUPPL-15 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
10/21/2020 KALETRA
NDA #021906		 SUPPL-54 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/21/2020 VALCYTE
NDA #022257		 SUPPL-10 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Manufacturing (CMC) Approval
10/21/2020 VELETRI
NDA #022260		 SUPPL-12 EPOPROSTENOL SODIUM ACTELION Labeling Approval
10/21/2020 OZURDEX
NDA #022315		 SUPPL-13 DEXAMETHASONE ABBVIE Labeling Approval
10/21/2020 NORVIR
NDA #022417		 SUPPL-24 RITONAVIR ABBVIE Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661		 SUPPL-14 GABAPENTIN RUBICON Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661		 SUPPL-16 GABAPENTIN RUBICON Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661		 SUPPL-18 GABAPENTIN RUBICON Labeling Approval
10/21/2020 GABAPENTIN
ANDA #077661		 SUPPL-19 GABAPENTIN RUBICON Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528		 SUPPL-10 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528		 SUPPL-11 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528		 SUPPL-12 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078528		 SUPPL-13 RISPERIDONE SANDOZ Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078740		 SUPPL-6 RISPERIDONE WEST WARD PHARMS Labeling Approval
10/21/2020 RISPERIDONE
ANDA #078740		 SUPPL-7 RISPERIDONE WEST WARD PHARMS Labeling Approval
10/21/2020 LOSARTAN POTASSIUM
ANDA #090083		 SUPPL-17 LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
10/21/2020 PALONOSETRON HYDROCHLORIDE
ANDA #202521		 SUPPL-4 PALONOSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/21/2020 CYANOCOBALAMIN
ANDA #206503		 SUPPL-4 CYANOCOBALAMIN SOMERSET THERAPS LLC Labeling Approval
10/21/2020 CYANOCOBALAMIN
ANDA #206503		 SUPPL-5 CYANOCOBALAMIN SOMERSET THERAPS LLC Labeling Approval
10/21/2020 CYANOCOBALAMIN
ANDA #206503		 SUPPL-7 CYANOCOBALAMIN SOMERSET THERAPS LLC Labeling Approval
10/21/2020 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #207128		 ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE CHARTWELL RX Approval
10/21/2020 TIGECYCLINE
NDA #208744		 SUPPL-3 TIGECYCLINE ACCORD HLTHCARE INC Labeling Approval
10/21/2020 SELENIOUS ACID
NDA #209379		 SUPPL-3 SELENIOUS ACID AM REGENT Labeling Approval
10/21/2020 NORVIR
NDA #209512		 SUPPL-7 RITONAVIR ABBVIE Labeling Approval
10/21/2020 DOXEPIN HYDROCHLORIDE
ANDA #210675		 SUPPL-1 DOXEPIN HYDROCHLORIDE EPIC PHARMA LLC Approval
10/21/2020 ACETAMINOPHEN
ANDA #210969		 ORIG-1 ACETAMINOPHEN EUGIA PHARMA Approval
10/21/2020 APREPITANT
ANDA #211835		 ORIG-1 APREPITANT TORRENT Approval
10/21/2020 TAVABOROLE
ANDA #212188		 ORIG-1 TAVABOROLE ALEMBIC Approval
10/21/2020 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #213530		 SUPPL-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CHARTWELL RX Approval
10/21/2020 METAXALONE
ANDA #213836		 ORIG-1 METAXALONE INGENUS PHARMS LLC Approval
10/21/2020 IBUPROFEN
ANDA #214003		 SUPPL-1 IBUPROFEN YICHANG HUMANWELL Approval
10/21/2020 VENLAFAXINE HYDROCHLORIDE
ANDA #214419		 ORIG-1 VENLAFAXINE HYDROCHLORIDE ASCENT PHARMS INC Approval
10/21/2020 POTASSIUM CHLORIDE
ANDA #214452		 ORIG-1 POTASSIUM CHLORIDE GRANULES Approval
10/22/2020 GANIRELIX ACETATE
NDA #021057		 SUPPL-20 GANIRELIX ACETATE ORGANON USA ORGANON Labeling Approval
10/22/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076282		 SUPPL-4 TIZANIDINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
10/22/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076286		 SUPPL-15 TIZANIDINE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
10/22/2020 DOLISHALE
ANDA #091692		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL NOVAST LABS Approval
10/22/2020 CAMPATH
BLA #103948		 SUPPL-5181 ALEMTUZUMAB GENZYME Approval
10/22/2020 LEMTRADA
BLA #103948		 SUPPL-5181 ALEMTUZUMAB GENZYME Approval
10/22/2020 COMETRIQ
NDA #203756		 SUPPL-9 CABOZANTINIB S-MALATE EXELIXIS Labeling Approval
10/22/2020 SILDENAFIL CITRATE
ANDA #203988		 SUPPL-3 SILDENAFIL CITRATE EUGIA PHARMA Labeling Approval
10/22/2020 FEBUXOSTAT
ANDA #205374		 ORIG-1 FEBUXOSTAT DR REDDYS Approval
10/22/2020 SIVEXTRO
NDA #205435		 SUPPL-13 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
10/22/2020 SIVEXTRO
NDA #205436		 SUPPL-8 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
10/22/2020 CHOLBAM
NDA #205750		 SUPPL-3 CHOLIC ACID MIRUM Labeling Approval
10/22/2020 ALBUTEROL SULFATE
ANDA #208884		 ORIG-1 ALBUTEROL SULFATE ZYDUS PHARMS Approval
10/22/2020 BACLOFEN
ANDA #209594		 SUPPL-1 BACLOFEN MYLAN LABS LTD Labeling Approval
10/22/2020 BACLOFEN
ANDA #209594		 SUPPL-2 BACLOFEN MYLAN LABS LTD Labeling Approval
10/22/2020 EPIDIOLEX
NDA #210365		 SUPPL-8 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
10/22/2020 OLANZAPINE
ANDA #210968		 ORIG-1 OLANZAPINE EUGIA PHARMA Approval
10/22/2020 TALZENNA
NDA #211651		 SUPPL-6 TALAZOPARIB TOSYLATE PFIZER Efficacy Approval
10/22/2020 TIMOLOL MALEATE
ANDA #212942		 ORIG-1 TIMOLOL MALEATE ALEMBIC Approval
10/22/2020 CARMUSTINE
ANDA #213207		 ORIG-1 CARMUSTINE DR REDDYS Approval
10/22/2020 LEUCOVORIN CALCIUM
ANDA #213929		 ORIG-1 LEUCOVORIN CALCIUM LEADING Approval
10/22/2020 VEKLURY
NDA #214787		 ORIG-1 REMDESIVIR GILEAD SCIENCES INC Type 1 - New Molecular Entity Approval
10/23/2020 SYMBYAX
NDA #021520		 SUPPL-51 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
10/23/2020 RAMIPRIL
ANDA #076549		 SUPPL-18 RAMIPRIL WATSON LABS Labeling Approval
10/23/2020 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
ANDA #202509		 SUPPL-11 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
10/23/2020 XTANDI
NDA #203415		 SUPPL-16 ENZALUTAMIDE ASTELLAS Efficacy Approval
10/23/2020 FLUDEOXYGLUCOSE F18
ANDA #204498		 SUPPL-2 FLUDEOXYGLUCOSE F-18 UNIV UTAH CYCLOTRON Labeling Approval
10/23/2020 TYMLOS
NDA #208743		 SUPPL-7 ABALOPARATIDE RADIUS Labeling Approval
10/23/2020 VYLEESI (AUTOINJECTOR)
NDA #210557		 SUPPL-2 BREMELANOTIDE ACETATE COSETTE Labeling Approval
10/23/2020 EZETIMIBE
ANDA #210673		 ORIG-1 EZETIMIBE SCIEGEN PHARMS INC Approval
10/23/2020 DICLOFENAC SODIUM
ANDA #211253		 SUPPL-7 DICLOFENAC SODIUM PERRIGO PHARMA INTL Manufacturing (CMC) Approval
10/23/2020 DICLOFENAC SODIUM
ANDA #211253		 SUPPL-10 DICLOFENAC SODIUM PERRIGO PHARMA INTL Manufacturing (CMC) Approval
10/23/2020 TADALAFIL
ANDA #211298		 ORIG-1 TADALAFIL UMEDICA Approval
10/23/2020 ZILEUTON
ANDA #211390		 ORIG-1 ZILEUTON AIZANT Approval
10/23/2020 BUSULFAN
ANDA #212127		 ORIG-1 BUSULFAN MEITHEAL Approval
10/23/2020 CLOFARABINE
ANDA #213461		 ORIG-1 CLOFARABINE MEITHEAL Approval
10/26/2020 TROPHAMINE
NDA #019018		 SUPPL-36 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
10/26/2020 TROPHAMINE 10%
NDA #019018		 SUPPL-36 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
10/26/2020 SURVANTA
BLA #020032		 SUPPL-46 BERACTANT ABBVIE Approval
10/26/2020 VALACYCLOVIR HYDROCHLORIDE
ANDA #077478		 SUPPL-13 VALACYCLOVIR HYDROCHLORIDE SANDOZ Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894		 SUPPL-7 GABAPENTIN APOTEX Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894		 SUPPL-8 GABAPENTIN APOTEX Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894		 SUPPL-9 GABAPENTIN APOTEX Labeling Approval
10/26/2020 GABAPENTIN
ANDA #077894		 SUPPL-10 GABAPENTIN APOTEX Labeling Approval
10/26/2020 NARATRIPTAN
ANDA #200502		 SUPPL-4 NARATRIPTAN HYDROCHLORIDE HERITAGE PHARMS Labeling Approval
10/26/2020 ADEFOVIR DIPIVOXIL
ANDA #202051		 SUPPL-4 ADEFOVIR DIPIVOXIL SIGMAPHARM LABS LLC Labeling Approval
10/26/2020 DABIGATRAN ETEXILATE MESYLATE
ANDA #208048		 ORIG-1 DABIGATRAN ETEXILATE MESYLATE DR REDDYS LABS LTD Tentative Approval
10/26/2020 XERMELO
NDA #208794		 SUPPL-1 TELOTRISTAT ETIPRATE TERSERA Labeling Approval
10/26/2020 EYSUVIS
NDA #210933		 ORIG-1 LOTEPREDNOL ETABONATE ALCON LABS INC Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
10/26/2020 RAMELTEON
ANDA #213815		 ORIG-1 RAMELTEON UPSHER SMITH LABS Approval
10/26/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #214256		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE SUN PHARM Approval
10/27/2020 ELESTRIN
NDA #021813		 SUPPL-7 ESTRADIOL MYLAN SPECIALITY LP Labeling Approval
10/27/2020 ELESTRIN
NDA #021813		 SUPPL-9 ESTRADIOL MYLAN SPECIALITY LP Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077242		 SUPPL-27 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525		 SUPPL-20 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525		 SUPPL-24 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525		 SUPPL-26 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077525		 SUPPL-34 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077662		 SUPPL-23 GABAPENTIN GLENMARK PHARMS LTD Labeling Approval
10/27/2020 GABAPENTIN
ANDA #077662		 SUPPL-26 GABAPENTIN GLENMARK PHARMS LTD Labeling Approval
10/27/2020 OXCARBAZEPINE
ANDA #078005		 SUPPL-6 OXCARBAZEPINE ANI PHARMS Labeling Approval
10/27/2020 OXCARBAZEPINE
ANDA #078005		 SUPPL-7 OXCARBAZEPINE ANI PHARMS Labeling Approval
10/27/2020 SKLICE
NDA #202736		 SUPPL-6 IVERMECTIN ARBOR PHARMS LLC Efficacy Approval
10/27/2020 ZOLEDRONIC ACID
NDA #203231		 SUPPL-15 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/27/2020 ZOLEDRONIC ACID
NDA #203231		 SUPPL-16 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/27/2020 ZOLEDRONIC ACID
NDA #203231		 SUPPL-17 ZOLEDRONIC ACID INFORLIFE Labeling Approval
10/27/2020 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #207966		 ORIG-1 MAGNESIUM SULFATE B BRAUN MEDICAL INC Approval
10/27/2020 TADALAFIL
ANDA #208824		 ORIG-1 TADALAFIL HANGZHOU BINJIANG Approval
10/27/2020 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #209665		 ORIG-1 CISATRACURIUM BESYLATE EUGIA PHARMA Approval
10/27/2020 BAQSIMI
NDA #210134		 SUPPL-2 GLUCAGON AMPHASTAR PHARMS INC Labeling Approval
10/27/2020 AKYNZEO
NDA #210493		 SUPPL-3 FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Manufacturing (CMC) Approval
10/27/2020 PHENOXYBENZAMINE HYDROCHLORIDE
ANDA #212568		 ORIG-1 PHENOXYBENZAMINE HYDROCHLORIDE AMNEAL Approval
10/27/2020 PALBOCICLIB
ANDA #213066		 ORIG-1 PALBOCICLIB APOTEX INC Tentative Approval
10/27/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #213552		 ORIG-1 SUCCINYLCHOLINE CHLORIDE NEXUS Approval
10/27/2020 AMPHETAMINE SULFATE
ANDA #213720		 ORIG-1 AMPHETAMINE SULFATE ALKEM LABS LTD Approval
10/27/2020 AMPHETAMINE SULFATE
ANDA #213980		 ORIG-1 AMPHETAMINE SULFATE EPIC PHARMA LLC Approval
10/27/2020 OXYBUTYNIN CHLORIDE
ANDA #214415		 ORIG-1 OXYBUTYNIN CHLORIDE RUBICON Approval
10/28/2020 FOSCAVIR
NDA #020068		 SUPPL-25 FOSCARNET SODIUM CLINIGEN HLTHCARE Manufacturing (CMC) Approval
10/28/2020 ALEVE
NDA #020204		 SUPPL-76 NAPROXEN SODIUM BAYER Labeling Approval
10/28/2020 ANASTROZOLE
ANDA #078058		 SUPPL-11 ANASTROZOLE TEVA PHARMS Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926		 SUPPL-9 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926		 SUPPL-10 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926		 SUPPL-12 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926		 SUPPL-15 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 GABAPENTIN
ANDA #078926		 SUPPL-17 GABAPENTIN ZYDUS PHARMS USA INC Labeling Approval
10/28/2020 RISPERIDONE
ANDA #091537		 SUPPL-9 RISPERIDONE DASH PHARMS Labeling Approval
10/28/2020 RISPERIDONE
ANDA #091537		 SUPPL-10 RISPERIDONE DASH PHARMS Labeling Approval
10/28/2020 OXCARBAZEPINE
ANDA #201193		 SUPPL-4 OXCARBAZEPINE HIKMA Labeling Approval
10/28/2020 OXCARBAZEPINE
ANDA #201193		 SUPPL-5 OXCARBAZEPINE HIKMA Labeling Approval
10/28/2020 OFEV
NDA #205832		 SUPPL-14 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Labeling Approval
10/28/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #207991		 ORIG-1 FINGOLIMOD HYDROCHLORIDE ACCORD HLTHCARE Approval
10/28/2020 ZINC SULFATE
NDA #209377		 SUPPL-3 ZINC SULFATE AM REGENT Labeling Approval
10/28/2020 CAPECITABINE
ANDA #210604		 SUPPL-1 CAPECITABINE EUGIA PHARMA Labeling Approval
10/28/2020 CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #210906		 SUPPL-4 CALCIUM GLUCONATE HQ SPCLT PHARMA Labeling Approval
10/28/2020 LEVOTHYROXINE SODIUM
ANDA #211369		 ORIG-1 LEVOTHYROXINE SODIUM TEVA PHARMS USA INC Approval
10/28/2020 ACCRUFER
NDA #212320		 SUPPL-5 FERRIC MALTOL SHIELD TX Labeling Approval
10/28/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #213936		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ACCORD HLTHCARE Approval
10/29/2020 PENTASA
NDA #020049		 SUPPL-34 MESALAMINE TAKEDA PHARMS USA Labeling Approval
10/29/2020 GEODON
NDA #020825		 SUPPL-61 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
10/29/2020 GEODON
NDA #020919		 SUPPL-49 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
10/29/2020 SILENOR
NDA #022036		 SUPPL-6 DOXEPIN HYDROCHLORIDE CURRAX Labeling Approval
10/29/2020 METHOTREXATE SODIUM
ANDA #040054		 SUPPL-15 METHOTREXATE SODIUM HIKMA Labeling Approval
10/29/2020 METHOTREXATE SODIUM
ANDA #040054		 SUPPL-16 METHOTREXATE SODIUM HIKMA Labeling Approval
10/29/2020 METHOTREXATE SODIUM
ANDA #040054		 SUPPL-17 METHOTREXATE SODIUM HIKMA Labeling Approval
10/29/2020 SOTALOL HYDROCHLORIDE
ANDA #075563		 SUPPL-18 SOTALOL HYDROCHLORIDE OXFORD PHARMS Labeling Approval
10/29/2020 BACLOFEN
ANDA #077241		 SUPPL-20 BACLOFEN LANNETT CO INC Labeling Approval
10/29/2020 TESTOSTERONE ENANTHATE
ANDA #091120		 SUPPL-4 TESTOSTERONE ENANTHATE HIKMA FARMACEUTICA Labeling Approval
10/29/2020 FENOFIBRIC ACID
ANDA #201573		 SUPPL-10 CHOLINE FENOFIBRATE ENDO OPERATIONS Labeling Approval
10/29/2020 TRANEXAMIC ACID
ANDA #202436		 SUPPL-5 TRANEXAMIC ACID ACIC PHARMS Labeling Approval
10/29/2020 QUETIAPINE FUMARATE
ANDA #204253		 SUPPL-11 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 QUETIAPINE FUMARATE
ANDA #204253		 SUPPL-12 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 GUANFACINE HYDROCHLORIDE
ANDA #205430		 SUPPL-2 GUANFACINE HYDROCHLORIDE APOTEX Labeling Approval
10/29/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156		 SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #206156		 SUPPL-16 PRAMIPEXOLE DIHYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
10/29/2020 BUPROPION HYDROCHLORIDE
ANDA #207389		 SUPPL-5 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
10/29/2020 TICAGRELOR
ANDA #208541		 ORIG-1 TICAGRELOR DR REDDYS LABS INC Tentative Approval
10/29/2020 ENDARI
NDA #208587		 SUPPL-3 L-GLUTAMINE EMMAUS MEDCL Labeling Approval
10/29/2020 TRULANCE
NDA #208745		 SUPPL-10 PLECANATIDE SALIX Labeling Approval
10/29/2020 SODIUM NITROPRUSSIDE
ANDA #211277		 ORIG-1 SODIUM NITROPRUSSIDE XIROMED Approval
10/29/2020 PALIPERIDONE
ANDA #212807		 ORIG-1 PALIPERIDONE CSPC OUYI Approval
10/30/2020 SELZENTRY
NDA #022128		 SUPPL-19 MARAVIROC VIIV HLTHCARE Efficacy Approval
10/30/2020 TESTOSTERONE ENANTHATE
ANDA #040575		 SUPPL-10 TESTOSTERONE ENANTHATE NEXUS Labeling Approval
10/30/2020 VALPROIC ACID
ANDA #073178		 SUPPL-24 VALPROIC ACID ANI PHARMS Labeling Approval
10/30/2020 VALPROIC ACID
ANDA #073178		 SUPPL-25 VALPROIC ACID ANI PHARMS Labeling Approval
10/30/2020 VALPROIC ACID
ANDA #073178		 SUPPL-26 VALPROIC ACID ANI PHARMS Labeling Approval
10/30/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076281		 SUPPL-7 TIZANIDINE HYDROCHLORIDE OXFORD PHARMS Labeling Approval
10/30/2020 TIZANIDINE HYDROCHLORIDE
ANDA #076371		 SUPPL-3 TIZANIDINE HYDROCHLORIDE ANI PHARMS Labeling Approval
10/30/2020 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #076684		 SUPPL-11 ENOXAPARIN SODIUM AMPHASTAR PHARM Labeling Approval
10/30/2020 BRONCHITOL
NDA #202049		 ORIG-1 MANNITOL CHIESI Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
10/30/2020 TRAZODONE HYDROCHLORIDE
ANDA #205253		 SUPPL-8 TRAZODONE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
10/30/2020 MONTELUKAST SODIUM
ANDA #205319		 ORIG-1 MONTELUKAST SODIUM BRECKENRIDGE Approval
10/30/2020 ALEVE PM
NDA #205352		 SUPPL-15 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
10/30/2020 SOLIFENACIN SUCCINATE
ANDA #205575		 SUPPL-4 SOLIFENACIN SUCCINATE ALEMBIC Labeling Approval
10/30/2020 PALIPERIDONE
ANDA #205618		 SUPPL-2 PALIPERIDONE SUN PHARM Labeling Approval
10/30/2020 PALIPERIDONE
ANDA #205618		 SUPPL-4 PALIPERIDONE SUN PHARM Labeling Approval
10/30/2020 SELZENTRY
NDA #208984		 SUPPL-2 MARAVIROC VIIV HLTHCARE Efficacy Approval
10/30/2020 QUETIAPINE FUMARATE
ANDA #209635		 SUPPL-8 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
10/30/2020 QUETIAPINE FUMARATE
ANDA #209635		 SUPPL-9 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
10/30/2020 QUETIAPINE FUMARATE
ANDA #209635		 SUPPL-10 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
10/30/2020 POMALIDOMIDE
ANDA #210111		 ORIG-1 POMALIDOMIDE BRECKENRIDGE Approval
10/30/2020 POMALIDOMIDE
ANDA #210249		 ORIG-1 POMALIDOMIDE EUGIA PHARMA Approval
10/30/2020 NOREPINEPHRINE BITARTRATE
ANDA #210839		 SUPPL-6 NOREPINEPHRINE BITARTRATE AMNEAL Labeling Approval
10/30/2020 TRIJARDY XR
NDA #212614		 SUPPL-4 EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
10/30/2020 LORATADINE
ANDA #213294		 ORIG-1 LORATADINE TENSHI Approval
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