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 |