10/01/2021 |
RISPERIDONE ANDA #076288 |
SUPPL-20 |
RISPERIDONE |
DASH PHARMS |
Labeling |
Approval |
10/01/2021 |
LITHIUM CARBONATE ANDA #090702 |
SUPPL-7 |
LITHIUM CARBONATE |
HETERO LABS LTD III |
Labeling |
Approval |
10/01/2021 |
LITHIUM CARBONATE ANDA #090702 |
SUPPL-10 |
LITHIUM CARBONATE |
HETERO LABS LTD III |
Labeling |
Approval |
10/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #091483 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
10/01/2021 |
RAMIPRIL ANDA #091604 |
SUPPL-10 |
RAMIPRIL |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
10/01/2021 |
LEVETIRACETAM ANDA #201464 |
SUPPL-3 |
LEVETIRACETAM |
PHARMADAX INC |
Labeling |
Approval |
10/01/2021 |
EZETIMIBE AND SIMVASTATIN ANDA #202968 |
SUPPL-5 |
EZETIMIBE; SIMVASTATIN |
WATSON LABS INC |
Labeling |
Approval |
10/01/2021 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #206845 |
SUPPL-2 |
ONDANSETRON HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
10/01/2021 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ANDA #206845 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
10/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #206846 |
SUPPL-2 |
ONDANSETRON HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
10/01/2021 |
ONDANSETRON HYDROCHLORIDE ANDA #206846 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
10/01/2021 |
JENTADUETO XR NDA #208026 |
SUPPL-20 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
10/01/2021 |
NEOSTIGMINE METHYLSULFATE ANDA #210652 |
ORIG-1 |
NEOSTIGMINE METHYLSULFATE |
ADAPTIS |
|
Approval |
10/01/2021 |
CASPOFUNGIN ACETATE ANDA #211263 |
ORIG-1 |
CASPOFUNGIN ACETATE |
AREVA PHARMS |
|
Approval |
10/01/2021 |
TALICIA NDA #213004 |
SUPPL-4 |
AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN |
REDHILL |
Labeling |
Approval |
10/01/2021 |
MEXILETINE HYDROCHLORIDE ANDA #214089 |
ORIG-1 |
MEXILETINE HYDROCHLORIDE |
SENORES PHARMS |
|
Approval |
10/01/2021 |
GABAPENTIN ANDA #214957 |
ORIG-1 |
GABAPENTIN |
ASCENT PHARMS INC |
|
Approval |
10/01/2021 |
OSELTAMIVIR PHOSPHATE ANDA #215208 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
EPIC PHARMA LLC |
|
Approval |
10/01/2021 |
DUPIXENT BLA #761055 |
SUPPL-35 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
10/01/2021 |
SOGROYA BLA #761156 |
SUPPL-1 |
SOMAPACITAN-BECO |
NOVO NORDISK INC |
|
Approval |
10/01/2021 |
SOGROYA BLA #761156 |
SUPPL-2 |
SOMAPACITAN-BECO |
NOVO NORDISK INC |
|
Approval |
10/04/2021 |
ESTRADIOL NDA #020538 |
SUPPL-37 |
ESTRADIOL |
SANDOZ |
Labeling |
Approval |
10/04/2021 |
ESTRADIOL NDA #020538 |
SUPPL-39 |
ESTRADIOL |
SANDOZ |
Labeling |
Approval |
10/04/2021 |
VIVELLE-DOT NDA #020538 |
SUPPL-37 |
ESTRADIOL |
SANDOZ |
Labeling |
Approval |
10/04/2021 |
VIVELLE-DOT NDA #020538 |
SUPPL-39 |
ESTRADIOL |
SANDOZ |
Labeling |
Approval |
10/04/2021 |
VENCLEXTA NDA #208573 |
SUPPL-24 |
VENETOCLAX |
ABBVIE |
Efficacy |
Approval |
10/04/2021 |
TRIKAFTA (COPACKAGED) NDA #212273 |
SUPPL-8 |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
VERTEX PHARMS INC |
Labeling |
Approval |
10/04/2021 |
FOSAPREPITANT DIMEGLUMINE ANDA #213199 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
ARTHUR GRP |
|
Approval |
10/04/2021 |
OXYMETAZOLINE HYDROCHLORIDE ANDA #213584 |
ORIG-1 |
OXYMETAZOLINE HYDROCHLORIDE |
TARO |
|
Approval |
10/04/2021 |
SERTRALINE HYDROCHLORIDE NDA #215133 |
ORIG-1 |
SERTRALINE HYDROCHLORIDE |
ALMATICA |
Type 3 - New Dosage Form |
Approval |
10/04/2021 |
SERTRALINE HYDROCHLORIDE NDA #215133 |
ORIG-2 |
SERTRALINE HYDROCHLORIDE |
ALMATICA |
Type 3 - New Dosage Form |
Approval |
10/05/2021 |
REMICADE BLA #103772 |
SUPPL-5401 |
INFLIXIMAB |
CENTOCOR INC |
|
Approval |
10/05/2021 |
VALSARTAN ANDA #201618 |
ORIG-1 |
VALSARTAN |
DR REDDYS |
|
Approval |
10/05/2021 |
CARBIDOPA AND LEVODOPA ANDA #214091 |
ORIG-1 |
CARBIDOPA; LEVODOPA |
SCIEGEN PHARMS INC |
|
Approval |
10/06/2021 |
PROZAC NDA #018936 |
SUPPL-111 |
FLUOXETINE HYDROCHLORIDE |
ELI LILLY AND CO |
Labeling |
Approval |
10/06/2021 |
SARAFEM NDA #018936 |
SUPPL-111 |
FLUOXETINE HYDROCHLORIDE |
ELI LILLY AND CO |
Labeling |
Approval |
10/06/2021 |
FLUCONAZOLE ANDA #076077 |
SUPPL-18 |
FLUCONAZOLE |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
10/06/2021 |
FLUCONAZOLE ANDA #077253 |
SUPPL-18 |
FLUCONAZOLE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
10/06/2021 |
FLUCONAZOLE ANDA #077731 |
SUPPL-23 |
FLUCONAZOLE |
AUROBINDO PHARMA |
Labeling |
Approval |
10/06/2021 |
FLUCONAZOLE ANDA #208963 |
SUPPL-9 |
FLUCONAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
10/06/2021 |
ASPIRIN AND DIPYRIDAMOLE ANDA #209048 |
SUPPL-2 |
ASPIRIN; DIPYRIDAMOLE |
DR REDDYS |
Labeling |
Approval |
10/06/2021 |
ASPIRIN AND DIPYRIDAMOLE ANDA #209048 |
SUPPL-5 |
ASPIRIN; DIPYRIDAMOLE |
DR REDDYS |
Labeling |
Approval |
10/06/2021 |
SUGAMMADEX SODIUM ANDA #214364 |
ORIG-1 |
SUGAMMADEX SODIUM |
GLAND PHARMA LTD |
|
Tentative Approval |
10/06/2021 |
LOPERAMIDE HYDROCHLORIDE ANDA #215001 |
ORIG-1 |
LOPERAMIDE HYDROCHLORIDE |
EDENBRIDGE PHARMS |
|
Approval |
10/06/2021 |
TECENTRIQ BLA #761034 |
SUPPL-44 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
10/07/2021 |
CLIMARA PRO NDA #021258 |
SUPPL-13 |
ESTRADIOL; LEVONORGESTREL |
BAYER HLTHCARE |
Labeling |
Approval |
10/07/2021 |
EFAVIRENZ ANDA #091471 |
SUPPL-2 |
EFAVIRENZ |
MYLAN |
Labeling |
Approval |
10/07/2021 |
EFAVIRENZ ANDA #091471 |
SUPPL-4 |
EFAVIRENZ |
MYLAN |
Labeling |
Approval |
10/07/2021 |
EFAVIRENZ ANDA #091471 |
SUPPL-5 |
EFAVIRENZ |
MYLAN |
Labeling |
Approval |
10/07/2021 |
LEVETIRACETAM ANDA #091491 |
SUPPL-11 |
LEVETIRACETAM |
ZHEJIANG JINGXIN |
Labeling |
Approval |
10/07/2021 |
LEVETIRACETAM ANDA #091491 |
SUPPL-12 |
LEVETIRACETAM |
ZHEJIANG JINGXIN |
Labeling |
Approval |
10/07/2021 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE ANDA #201806 |
ORIG-1 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
HETERO LABS LTD III |
|
Approval |
10/07/2021 |
TOPICORT NDA #204141 |
SUPPL-9 |
DESOXIMETASONE |
TARO |
Efficacy |
Approval |
10/07/2021 |
ZYKADIA NDA #205755 |
SUPPL-19 |
CERITINIB |
NOVARTIS |
Labeling |
Approval |
10/07/2021 |
DEXTENZA NDA #208742 |
SUPPL-7 |
DEXAMETHASONE |
OCULAR THERAPEUTIX |
Efficacy |
Approval |
10/07/2021 |
BIKTARVY NDA #210251 |
SUPPL-14 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
10/07/2021 |
ZYKADIA NDA #211225 |
SUPPL-4 |
CERITINIB |
NOVARTIS |
Labeling |
Approval |
10/07/2021 |
TAVNEOS NDA #214487 |
ORIG-1 |
AVACOPAN |
CHEMOCENTRYX |
Type 1 - New Molecular Entity |
Approval |
10/07/2021 |
FLUOROURACIL ANDA #214845 |
ORIG-1 |
FLUOROURACIL |
ACCORD HLTHCARE |
|
Approval |
10/07/2021 |
ARSENIC TRIOXIDE ANDA #215059 |
ORIG-1 |
ARSENIC TRIOXIDE |
GLAND PHARMA LTD |
|
Approval |
10/08/2021 |
ABSORICA NDA #021951 |
SUPPL-18 |
ISOTRETINOIN |
SUN PHARM INDS INC |
REMS |
Approval |
10/08/2021 |
CEFAZOLIN AND DEXTROSE NDA #050779 |
SUPPL-31 |
CEFAZOLIN SODIUM |
B BRAUN |
Labeling |
Approval |
10/08/2021 |
CEFUROXIME SODIUM ANDA #064124 |
SUPPL-18 |
CEFUROXIME SODIUM |
ACS DOBFAR SPA |
Labeling |
Approval |
10/08/2021 |
CEFUROXIME SODIUM ANDA #064125 |
SUPPL-13 |
CEFUROXIME SODIUM |
ACS DOBFAR SPA |
Labeling |
Approval |
10/08/2021 |
FLUOXETINE ANDA #075662 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
10/08/2021 |
AMNESTEEM ANDA #075945 |
SUPPL-40 |
ISOTRETINOIN |
MYLAN PHARMS INC |
REMS |
Approval |
10/08/2021 |
CLARAVIS ANDA #076135 |
SUPPL-52 |
ISOTRETINOIN |
TEVA PHARMS USA |
REMS |
Approval |
10/08/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076237 |
SUPPL-6 |
FLUOXETINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
10/08/2021 |
FLUOXETINE HYDROCHLORIDE ANDA #076237 |
SUPPL-7 |
FLUOXETINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
10/08/2021 |
CLARAVIS ANDA #076356 |
SUPPL-47 |
ISOTRETINOIN |
TEVA PHARMS USA |
REMS |
Approval |
10/08/2021 |
MYORISAN ANDA #076485 |
SUPPL-27 |
ISOTRETINOIN |
UPSHER SMITH LABS |
REMS |
Approval |
10/08/2021 |
ZENATANE ANDA #202099 |
SUPPL-24 |
ISOTRETINOIN |
DR REDDYS LABS LTD |
REMS |
Approval |
10/08/2021 |
ISOTRETINOIN ANDA #205063 |
SUPPL-1 |
ISOTRETINOIN |
ACTAVIS LABS FL |
REMS |
Approval |
10/08/2021 |
ISOTRETINOIN ANDA #207792 |
SUPPL-14 |
ISOTRETINOIN |
AMNEAL PHARMS NY |
REMS |
Approval |
10/08/2021 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ANDA #207823 |
ORIG-1 |
METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE |
SUN PHARM INDS LTD |
|
Tentative Approval |
10/08/2021 |
ALVIMOPAN ANDA #208295 |
SUPPL-2 |
ALVIMOPAN |
WATSON LABS TEVA |
Labeling |
Approval |
10/08/2021 |
CLOBAZAM ANDA #209718 |
SUPPL-3 |
CLOBAZAM |
AMNEAL PHARMS CO |
Labeling |
Approval |
10/08/2021 |
CLOBAZAM ANDA #209795 |
SUPPL-2 |
CLOBAZAM |
HETERO LABS LTD III |
Labeling |
Approval |
10/08/2021 |
ABSORICA LD NDA #211913 |
SUPPL-4 |
ISOTRETINOIN |
SUN PHARM |
REMS |
Approval |
10/08/2021 |
ISOTRETINOIN ANDA #212333 |
SUPPL-1 |
ISOTRETINOIN |
UPSHER SMITH LABS |
REMS |
Approval |
10/08/2021 |
SILDENAFIL CITRATE ANDA #212883 |
SUPPL-3 |
SILDENAFIL CITRATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
10/08/2021 |
DASATINIB ANDA #213383 |
ORIG-1 |
DASATINIB |
DR REDDYS LABS LTD |
|
Tentative Approval |
10/08/2021 |
ISOTRETINOIN ANDA #213571 |
SUPPL-1 |
ISOTRETINOIN |
UPSHER SMITH LABS |
REMS |
Approval |
10/08/2021 |
PENICILLAMINE ANDA #214363 |
ORIG-1 |
PENICILLAMINE |
NAVINTA LLC |
|
Approval |
10/08/2021 |
DICLOFENAC POTASSIUM ANDA #215585 |
ORIG-1 |
DICLOFENAC POTASSIUM |
NOVAST LABS |
|
Approval |
10/12/2021 |
ELIQUIS NDA #202155 |
SUPPL-34 |
APIXABAN |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
10/12/2021 |
MINIVELLE NDA #203752 |
SUPPL-16 |
ESTRADIOL |
NOVEN |
Labeling |
Approval |
10/12/2021 |
ROMIDEPSIN ANDA #206254 |
ORIG-1 |
ROMIDEPSIN |
FRESENIUS KABI USA |
|
Approval |
10/12/2021 |
PROPOFOL ANDA #206408 |
ORIG-1 |
PROPOFOL |
AVET LIFESCIENCES |
|
Approval |
10/12/2021 |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) ANDA #207228 |
ORIG-1 |
DOXORUBICIN HYDROCHLORIDE |
AYANA PHARMA LTD |
|
Approval |
10/12/2021 |
VERZENIO NDA #208716 |
SUPPL-6 |
ABEMACICLIB |
ELI LILLY AND CO |
Efficacy |
Approval |
10/12/2021 |
VERZENIO NDA #208716 |
SUPPL-7 |
ABEMACICLIB |
ELI LILLY AND CO |
Efficacy |
Approval |
10/12/2021 |
VERZENIO NDA #208716 |
SUPPL-8 |
ABEMACICLIB |
ELI LILLY AND CO |
Efficacy |
Approval |
10/12/2021 |
MIVACURIUM CHLORIDE ANDA #209708 |
ORIG-1 |
MIVACURIUM CHLORIDE |
WOODWARD |
|
Approval |
10/12/2021 |
METHOTREXATE SODIUM ANDA #210040 |
SUPPL-1 |
METHOTREXATE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
10/12/2021 |
METHOTREXATE SODIUM ANDA #210040 |
SUPPL-8 |
METHOTREXATE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
10/13/2021 |
AGRYLIN NDA #020333 |
SUPPL-27 |
ANAGRELIDE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
10/13/2021 |
ALLEGRA ALLERGY NDA #020872 |
SUPPL-46 |
FEXOFENADINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
10/13/2021 |
ALLEGRA HIVES NDA #020872 |
SUPPL-46 |
FEXOFENADINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
10/13/2021 |
CHILDREN'S ALLEGRA ALLERGY NDA #020872 |
SUPPL-46 |
FEXOFENADINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
10/13/2021 |
CHILDREN'S ALLEGRA HIVES NDA #020872 |
SUPPL-46 |
FEXOFENADINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
10/13/2021 |
VFEND NDA #021266 |
SUPPL-51 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
10/13/2021 |
VFEND NDA #021267 |
SUPPL-61 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
10/13/2021 |
VFEND NDA #021630 |
SUPPL-40 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
10/13/2021 |
POLYETHYLENE GLYCOL 3350 ANDA #090685 |
SUPPL-11 |
POLYETHYLENE GLYCOL 3350 |
PPI-DAC |
Labeling |
Approval |
10/13/2021 |
POLYETHYLENE GLYCOL 3350 ANDA #090685 |
SUPPL-13 |
POLYETHYLENE GLYCOL 3350 |
PPI-DAC |
Labeling |
Approval |
10/13/2021 |
KEYTRUDA BLA #125514 |
SUPPL-121 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
10/13/2021 |
KEYTRUDA BLA #125514 |
SUPPL-122 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
10/13/2021 |
GLYCOPYRROLATE ANDA #212591 |
ORIG-1 |
GLYCOPYRROLATE |
UMEDICA |
|
Approval |
10/13/2021 |
CARGLUMIC ACID ANDA #213729 |
ORIG-1 |
CARGLUMIC ACID |
NOVITIUM PHARMA |
|
Approval |
10/14/2021 |
EFUDEX NDA #016831 |
SUPPL-63 |
FLUOROURACIL |
BAUSCH |
Labeling |
Approval |
10/14/2021 |
VIMPAT NDA #022253 |
SUPPL-49 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
10/14/2021 |
VIMPAT NDA #022254 |
SUPPL-39 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
10/14/2021 |
VIMPAT NDA #022255 |
SUPPL-31 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
10/14/2021 |
BELRAPZO NDA #205580 |
SUPPL-10 |
BENDAMUSTINE HYDROCHLORIDE |
EAGLE PHARMS |
Labeling |
Approval |
10/14/2021 |
COLESEVELAM HYDROCHLORIDE ANDA #206036 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
BEIJING TIDE PHARM |
|
Approval |
10/14/2021 |
BENDEKA NDA #208194 |
SUPPL-24 |
BENDAMUSTINE HYDROCHLORIDE |
EAGLE PHARMS |
Labeling |
Approval |
10/14/2021 |
LENALIDOMIDE ANDA #209348 |
ORIG-1 |
LENALIDOMIDE |
DR REDDYS |
|
Approval |
10/14/2021 |
BENZTROPINE MESYLATE ANDA #209442 |
ORIG-1 |
BENZTROPINE MESYLATE |
HIKMA |
|
Approval |
10/14/2021 |
DOPTELET NDA #210238 |
SUPPL-6 |
AVATROMBOPAG MALEATE |
AKARX INC |
Labeling |
Approval |
10/14/2021 |
DOFETILIDE ANDA #212750 |
ORIG-1 |
DOFETILIDE |
GRANULES |
|
Approval |
10/14/2021 |
METRONIDAZOLE ANDA #213648 |
ORIG-1 |
METRONIDAZOLE |
SOLARIS PHARMA CORP |
|
Approval |
10/14/2021 |
DEXAMETHASONE ANDA #215106 |
ORIG-1 |
DEXAMETHASONE |
AMNEAL |
|
Approval |
10/15/2021 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM NDA #018598 |
SUPPL-54 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
FOSUN PHARMA |
Labeling |
Approval |
10/15/2021 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH NDA #018598 |
SUPPL-54 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
FOSUN PHARMA |
Labeling |
Approval |
10/15/2021 |
SULFATRIM NDA #018615 |
SUPPL-80 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
PHARM ASSOC |
Labeling |
Approval |
10/15/2021 |
SULFATRIM PEDIATRIC NDA #018615 |
SUPPL-80 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
PHARM ASSOC |
Labeling |
Approval |
10/15/2021 |
COZAAR NDA #020386 |
SUPPL-64 |
LOSARTAN POTASSIUM |
ORGANON |
Labeling |
Approval |
10/15/2021 |
LO LOESTRIN FE NDA #022501 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
10/15/2021 |
TRI-LEGEST FE ANDA #076105 |
SUPPL-13 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
BARR |
Labeling |
Approval |
10/15/2021 |
LANSOPRAZOLE ANDA #077255 |
SUPPL-22 |
LANSOPRAZOLE |
TEVA PHARMS |
Labeling |
Approval |
10/15/2021 |
TELMISARTAN ANDA #090032 |
SUPPL-6 |
TELMISARTAN |
GLENMARK PHARMS LTD |
Manufacturing (CMC) |
Approval |
10/15/2021 |
LANSOPRAZOLE ANDA #090331 |
SUPPL-24 |
LANSOPRAZOLE |
SANDOZ |
Labeling |
Approval |
10/15/2021 |
LANSOPRAZOLE ANDA #090331 |
SUPPL-25 |
LANSOPRAZOLE |
SANDOZ |
Labeling |
Approval |
10/15/2021 |
MONTELUKAST SODIUM ANDA #090984 |
SUPPL-16 |
MONTELUKAST SODIUM |
TORRENT PHARMS LTD |
Labeling |
Approval |
10/15/2021 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-17 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
10/15/2021 |
LANSOPRAZOLE ANDA #091269 |
SUPPL-18 |
LANSOPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
10/15/2021 |
CAPECITABINE ANDA #200483 |
SUPPL-6 |
CAPECITABINE |
HIKMA |
Labeling |
Approval |
10/15/2021 |
GABAPENTIN ANDA #200651 |
SUPPL-22 |
GABAPENTIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
10/15/2021 |
MONTELUKAST SODIUM ANDA #201515 |
SUPPL-17 |
MONTELUKAST SODIUM |
TORRENT PHARMS LTD |
Labeling |
Approval |
10/15/2021 |
TRANEXAMIC ACID ANDA #203256 |
SUPPL-1 |
TRANEXAMIC ACID |
ANI PHARMS |
Labeling |
Approval |
10/15/2021 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANDA #203575 |
SUPPL-3 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
10/15/2021 |
MONTELUKAST SODIUM ANDA #210431 |
SUPPL-4 |
MONTELUKAST SODIUM |
TORRENT |
Labeling |
Approval |
10/15/2021 |
ZIMHI NDA #212854 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
ZMI PHARMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
10/15/2021 |
SEGLENTIS NDA #213426 |
ORIG-1 |
CELECOXIB; TRAMADOL HYDROCHLORIDE |
KOWA PHARMS |
Type 4 - New Combination |
Approval |
10/15/2021 |
TYRVAYA NDA #213978 |
ORIG-1 |
VARENICLINE TARTRATE |
OYSTER POINT PHARMA |
Type 3 - New Dosage Form |
Approval |
10/15/2021 |
ARSENIC TRIOXIDE ANDA #214011 |
ORIG-1 |
ARSENIC TRIOXIDE |
EUGIA PHARMA |
|
Approval |
10/15/2021 |
FAMOTIDINE ANDA #215689 |
ORIG-1 |
FAMOTIDINE |
ASCENT PHARMS INC |
|
Approval |
10/15/2021 |
TECENTRIQ BLA #761034 |
SUPPL-42 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
10/15/2021 |
CYLTEZO BLA #761058 |
SUPPL-8 |
ADALIMUMAB-ADBM |
BOEHRINGER INGELHEIM |
|
Approval |
10/18/2021 |
LOTRIMIN ULTRA NDA #021307 |
SUPPL-19 |
BUTENAFINE HYDROCHLORIDE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
10/18/2021 |
CHLORHEXIDINE GLUCONATE ANDA #074522 |
SUPPL-17 |
CHLORHEXIDINE GLUCONATE |
PHARM ASSOC |
Manufacturing (CMC) |
Approval |
10/18/2021 |
ALOSETRON HYDROCHLORIDE ANDA #200652 |
SUPPL-7 |
ALOSETRON HYDROCHLORIDE |
HIKMA |
REMS |
Approval |
10/18/2021 |
OXYBUTYNIN CHLORIDE ANDA #202332 |
SUPPL-7 |
OXYBUTYNIN CHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
10/18/2021 |
BUTALBITAL, ASPIRIN AND CAFFEINE ANDA #205230 |
ORIG-1 |
ASPIRIN; BUTALBITAL; CAFFEINE |
LGM PHARMA |
|
Approval |
10/18/2021 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #205588 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
10/18/2021 |
EVEROLIMUS ANDA #205775 |
ORIG-1 |
EVEROLIMUS |
ENDO OPERATIONS |
|
Approval |
10/18/2021 |
ALOSETRON HYDROCHLORIDE ANDA #206113 |
SUPPL-4 |
ALOSETRON HYDROCHLORIDE |
ENDO OPERATIONS |
REMS |
Approval |
10/18/2021 |
ALOSETRON HYDROCHLORIDE ANDA #206647 |
SUPPL-9 |
ALOSETRON HYDROCHLORIDE |
AMNEAL PHARMS |
REMS |
Approval |
10/18/2021 |
ALOSETRON HYDROCHLORIDE ANDA #209180 |
SUPPL-4 |
ALOSETRON HYDROCHLORIDE |
RISING PHARMA |
REMS |
Approval |
10/18/2021 |
ALOSETRON HYDROCHLORIDE ANDA #213614 |
SUPPL-10 |
ALOSETRON HYDROCHLORIDE |
MANKIND PHARMA |
REMS |
Approval |
10/18/2021 |
CARBON DIOXIDE, USP NDA #216614 |
ORIG-1 |
CARBON DIOXIDE |
MIDDLESEX GASES TECHNOLOGIES, INC. |
|
Approval |
10/19/2021 |
RELENZA NDA #021036 |
SUPPL-32 |
ZANAMIVIR |
GLAXOSMITHKLINE |
Labeling |
Approval |
10/19/2021 |
TAZICEF ANDA #062662 |
SUPPL-32 |
CEFTAZIDIME |
HOSPIRA |
Labeling |
Approval |
10/19/2021 |
TAZICEF ANDA #062662 |
SUPPL-37 |
CEFTAZIDIME |
HOSPIRA |
Labeling |
Approval |
10/19/2021 |
FUROSEMIDE ANDA #077941 |
SUPPL-1 |
FUROSEMIDE |
WOCKHARDT |
Labeling |
Approval |
10/19/2021 |
MINIVELLE NDA #203752 |
SUPPL-12 |
ESTRADIOL |
NOVEN |
Labeling |
Approval |
10/19/2021 |
MINIVELLE NDA #203752 |
SUPPL-13 |
ESTRADIOL |
NOVEN |
Labeling |
Approval |
10/19/2021 |
LOKELMA NDA #207078 |
SUPPL-7 |
SODIUM ZIRCONIUM CYCLOSILICATE |
ASTRAZENECA |
Labeling |
Approval |
10/19/2021 |
CHOLESTYRAMINE LIGHT ANDA #211799 |
ORIG-1 |
CHOLESTYRAMINE |
ALKEM LABS LTD |
|
Approval |
10/19/2021 |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE NDA #211844 |
SUPPL-1 |
MIDAZOLAM |
INFORLIFE |
Labeling |
Approval |
10/19/2021 |
CHOLESTYRAMINE ANDA #211856 |
ORIG-1 |
CHOLESTYRAMINE |
ALKEM LABS LTD |
|
Approval |
10/19/2021 |
DICLOFENAC POTASSIUM ANDA #213875 |
ORIG-1 |
DICLOFENAC POTASSIUM |
AUROBINDO PHARMA LTD |
|
Approval |
10/19/2021 |
SUCCINYLCHOLINE CHLORIDE ANDA #214514 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
MEITHEAL |
|
Approval |
10/20/2021 |
SANDOSTATIN NDA #019667 |
SUPPL-71 |
OCTREOTIDE ACETATE |
NOVARTIS |
Labeling |
Approval |
10/20/2021 |
ZOFRAN NDA #020007 |
SUPPL-49 |
ONDANSETRON HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
10/20/2021 |
ZOFRAN PRESERVATIVE FREE NDA #020007 |
SUPPL-49 |
ONDANSETRON HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
10/20/2021 |
ZOFRAN NDA #020103 |
SUPPL-38 |
ONDANSETRON HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
10/20/2021 |
SABRIL NDA #020427 |
SUPPL-25 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
10/20/2021 |
ZOFRAN NDA #020605 |
SUPPL-22 |
ONDANSETRON HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
10/20/2021 |
ZOFRAN ODT NDA #020781 |
SUPPL-22 |
ONDANSETRON |
SANDOZ |
Labeling |
Approval |
10/20/2021 |
WELCHOL NDA #021176 |
SUPPL-49 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
10/20/2021 |
SABRIL NDA #022006 |
SUPPL-26 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
10/20/2021 |
WELCHOL NDA #022362 |
SUPPL-29 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Efficacy |
Approval |
10/20/2021 |
METHIMAZOLE ANDA #040350 |
SUPPL-24 |
METHIMAZOLE |
MYLAN |
Labeling |
Approval |
10/20/2021 |
HYDROXYCHLOROQUINE SULFATE ANDA #040760 |
SUPPL-8 |
HYDROXYCHLOROQUINE SULFATE |
HIKMA PHARMS |
Labeling |
Approval |
10/20/2021 |
CEFTAZIDIME IN DEXTROSE CONTAINER NDA #050823 |
SUPPL-9 |
CEFTAZIDIME |
B BRAUN |
Labeling |
Approval |
10/20/2021 |
TIZANIDINE HYDROCHLORIDE ANDA #091502 |
SUPPL-3 |
TIZANIDINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
10/20/2021 |
METHIMAZOLE ANDA #202068 |
SUPPL-5 |
METHIMAZOLE |
RISING PHARMA |
Labeling |
Approval |
10/20/2021 |
TELMISARTAN AND AMLODIPINE ANDA #202517 |
SUPPL-4 |
AMLODIPINE BESYLATE; TELMISARTAN |
TORRENT |
Labeling |
Approval |
10/20/2021 |
TELMISARTAN AND AMLODIPINE ANDA #202517 |
SUPPL-7 |
AMLODIPINE BESYLATE; TELMISARTAN |
TORRENT |
Labeling |
Approval |
10/20/2021 |
ZOLMITRIPTAN ANDA #203186 |
SUPPL-3 |
ZOLMITRIPTAN |
NATCO PHARMA USA |
Labeling |
Approval |
10/20/2021 |
CLOBAZAM ANDA #209796 |
SUPPL-1 |
CLOBAZAM |
HETERO LABS LTD III |
Labeling |
Approval |
10/20/2021 |
SUNOSI NDA #211230 |
SUPPL-4 |
SOLRIAMFETOL HYDROCHLORIDE |
AXSOME MALTA |
Labeling |
Approval |
10/20/2021 |
CARISOPRODOL ANDA #211789 |
ORIG-1 |
CARISOPRODOL |
ALLIED |
|
Approval |
10/20/2021 |
TURALIO NDA #211810 |
SUPPL-7 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
Labeling |
Approval |
10/20/2021 |
POTASSIUM ACETATE ANDA #212692 |
ORIG-1 |
POTASSIUM ACETATE |
EXELA PHARMA |
|
Approval |
10/20/2021 |
FLUPHENAZINE HYDROCHLORIDE ANDA #215141 |
ORIG-1 |
FLUPHENAZINE HYDROCHLORIDE |
ZAMEER PHARMS |
|
Approval |
10/20/2021 |
MITOMYCIN ANDA #215687 |
ORIG-1 |
MITOMYCIN |
GLAND PHARMA LTD |
|
Approval |
10/20/2021 |
DUPIXENT BLA #761055 |
SUPPL-31 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
10/21/2021 |
HIBICLENS NDA #017768 |
SUPPL-55 |
CHLORHEXIDINE GLUCONATE |
MOLNLYCKE HLTH |
Manufacturing (CMC) |
Approval |
10/21/2021 |
MIDOL LIQUID GELS NDA #021472 |
SUPPL-15 |
IBUPROFEN |
BIONPHARMA |
Labeling |
Approval |
10/21/2021 |
OMEPRAZOLE NDA #022032 |
SUPPL-52 |
OMEPRAZOLE |
DEXCEL PHARMA |
Manufacturing (CMC) |
Approval |
10/21/2021 |
RIFADIN NDA #050420 |
SUPPL-86 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
10/21/2021 |
RIFADIN NDA #050627 |
SUPPL-29 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
10/21/2021 |
RIFATER NDA #050705 |
SUPPL-20 |
ISONIAZID; PYRAZINAMIDE; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
10/21/2021 |
DEFERIPRONE ANDA #213239 |
SUPPL-3 |
DEFERIPRONE |
HIKMA |
Labeling |
Approval |
10/21/2021 |
FOSFOMYCIN TROMETHAMINE ANDA #214554 |
ORIG-1 |
FOSFOMYCIN TROMETHAMINE |
ALKEM LABS LTD |
|
Approval |
10/22/2021 |
NOVOLOG BLA #020986 |
SUPPL-95 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
10/22/2021 |
NOVOLOG FLEXPEN BLA #020986 |
SUPPL-95 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
10/22/2021 |
NOVOLOG FLEXTOUCH BLA #020986 |
SUPPL-95 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
10/22/2021 |
NOVOLOG INNOLET BLA #020986 |
SUPPL-95 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
10/22/2021 |
NOVOLOG PENFILL BLA #020986 |
SUPPL-95 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
10/22/2021 |
CELLCEPT NDA #050722 |
SUPPL-45 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050722 |
SUPPL-46 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050723 |
SUPPL-45 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050723 |
SUPPL-46 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050758 |
SUPPL-42 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050758 |
SUPPL-43 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050759 |
SUPPL-50 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
CELLCEPT NDA #050759 |
SUPPL-51 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
10/22/2021 |
DILANTIN ANDA #084349 |
SUPPL-87 |
PHENYTOIN SODIUM |
VIATRIS |
Labeling |
Approval |
10/22/2021 |
DILANTIN ANDA #084427 |
SUPPL-44 |
PHENYTOIN |
PHARMACIA |
Labeling |
Approval |
10/22/2021 |
ACTEMRA BLA #125276 |
SUPPL-135 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
10/22/2021 |
ACTEMRA BLA #125472 |
SUPPL-45 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
10/22/2021 |
VENCLEXTA NDA #208573 |
SUPPL-26 |
VENETOCLAX |
ABBVIE |
Labeling |
Approval |
10/22/2021 |
XIPERE NDA #211950 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
BAUSCH AND LOMB INC |
Type 3 - New Dosage Form |
Approval |
10/22/2021 |
LOPERAMIDE HYDROCHLORIDE ANDA #215579 |
ORIG-1 |
LOPERAMIDE HYDROCHLORIDE |
BIONPHARMA |
|
Approval |
10/22/2021 |
SUSVIMO BLA #761197 |
ORIG-1 |
RANIBIZUMAB |
GENENTECH INC |
|
Approval |
10/25/2021 |
FORANE NDA #017624 |
SUPPL-40 |
ISOFLURANE |
BAXTER HLTHCARE |
Labeling |
Approval |
10/25/2021 |
DIFLUCAN NDA #019949 |
SUPPL-70 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
10/25/2021 |
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019950 |
SUPPL-69 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
10/25/2021 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% NDA #019950 |
SUPPL-69 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
10/25/2021 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #019950 |
SUPPL-69 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
10/25/2021 |
DIFLUCAN NDA #020090 |
SUPPL-51 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
10/25/2021 |
CANCIDAS NDA #021227 |
SUPPL-40 |
CASPOFUNGIN ACETATE |
MERCK |
Labeling |
Approval |
10/25/2021 |
VELCADE NDA #021602 |
SUPPL-45 |
BORTEZOMIB |
TAKEDA PHARMS USA |
Labeling |
Approval |
10/25/2021 |
ZYLET NDA #050804 |
SUPPL-26 |
LOTEPREDNOL ETABONATE; TOBRAMYCIN |
BAUSCH AND LOMB |
Labeling |
Approval |
10/25/2021 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM ANDA #077612 |
SUPPL-6 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
PRASCO |
Manufacturing (CMC) |
Approval |
10/25/2021 |
METOPROLOL TARTRATE ANDA #078085 |
SUPPL-13 |
METOPROLOL TARTRATE |
HOSPIRA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #089340 |
SUPPL-36 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #089340 |
SUPPL-39 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #089340 |
SUPPL-41 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM ANDA #089341 |
SUPPL-34 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM ANDA #089341 |
SUPPL-36 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM ANDA #089341 |
SUPPL-38 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM ANDA #089342 |
SUPPL-34 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM ANDA #089342 |
SUPPL-36 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM ANDA #089342 |
SUPPL-38 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #089343 |
SUPPL-34 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #089343 |
SUPPL-36 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #089343 |
SUPPL-38 |
METHOTREXATE SODIUM |
HIKMA |
Labeling |
Approval |
10/25/2021 |
VINBLASTINE SULFATE ANDA #089515 |
SUPPL-38 |
VINBLASTINE SULFATE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #090029 |
SUPPL-12 |
METHOTREXATE SODIUM |
SANDOZ |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #090029 |
SUPPL-13 |
METHOTREXATE SODIUM |
SANDOZ |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #090039 |
SUPPL-13 |
METHOTREXATE SODIUM |
SANDOZ |
Labeling |
Approval |
10/25/2021 |
METHOTREXATE SODIUM PRESERVATIVE FREE ANDA #090039 |
SUPPL-14 |
METHOTREXATE SODIUM |
SANDOZ |
Labeling |
Approval |
10/25/2021 |
OPSUMIT NDA #204410 |
SUPPL-22 |
MACITENTAN |
ACTELION |
Labeling |
Approval |
10/25/2021 |
PATADAY ONCE DAILY RELIEF NDA #206276 |
SUPPL-6 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Manufacturing (CMC) |
Approval |
10/25/2021 |
OXYCODONE HYDROCHLORIDE ANDA #207418 |
SUPPL-4 |
OXYCODONE HYDROCHLORIDE |
ASCENT PHARMS INC |
Labeling |
Approval |
10/25/2021 |
OXYCODONE HYDROCHLORIDE ANDA #207418 |
SUPPL-5 |
OXYCODONE HYDROCHLORIDE |
ASCENT PHARMS INC |
Labeling |
Approval |
10/25/2021 |
EPLERENONE ANDA #207842 |
ORIG-1 |
EPLERENONE |
WESTMINSTER PHARMS |
|
Approval |
10/25/2021 |
UPTRAVI NDA #207947 |
SUPPL-9 |
SELEXIPAG |
ACTELION |
Labeling |
Approval |
10/25/2021 |
LURASIDONE HYDROCHLORIDE ANDA #208058 |
SUPPL-1 |
LURASIDONE HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
10/25/2021 |
CLOBAZAM ANDA #209808 |
SUPPL-1 |
CLOBAZAM |
PIRAMAL HLTHCARE UK |
Labeling |
Approval |
10/25/2021 |
CLOBAZAM ANDA #209853 |
SUPPL-1 |
CLOBAZAM |
APOTEX |
Labeling |
Approval |
10/25/2021 |
SUCCINYLCHOLINE CHLORIDE ANDA #210698 |
SUPPL-7 |
SUCCINYLCHOLINE CHLORIDE |
DR REDDYS |
Labeling |
Approval |
10/25/2021 |
HEPARIN SODIUM ANDA #211004 |
SUPPL-4 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
Labeling |
Approval |
10/25/2021 |
HEPARIN SODIUM ANDA #211005 |
SUPPL-4 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
Labeling |
Approval |
10/25/2021 |
SUCCINYLCHOLINE CHLORIDE ANDA #213705 |
SUPPL-4 |
SUCCINYLCHOLINE CHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
10/25/2021 |
ATOVAQUONE ANDA #214272 |
ORIG-1 |
ATOVAQUONE |
ABON PHARMS LLC |
|
Approval |
10/25/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE ANDA #215555 |
ORIG-1 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
AMNEAL |
|
Approval |
10/25/2021 |
ATENOLOL AND CHLORTHALIDONE ANDA #215560 |
ORIG-1 |
ATENOLOL; CHLORTHALIDONE |
NOVITIUM PHARMA |
|
Approval |
10/25/2021 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #215659 |
ORIG-1 |
CHLORPROMAZINE HYDROCHLORIDE |
TEVA PHARMS |
|
Approval |
10/26/2021 |
ZYVOX NDA #021130 |
SUPPL-43 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
10/26/2021 |
ZYVOX NDA #021131 |
SUPPL-39 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
10/26/2021 |
ZYVOX NDA #021132 |
SUPPL-42 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
10/26/2021 |
CUBICIN NDA #021572 |
SUPPL-65 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
10/26/2021 |
CUBICIN NDA #021572 |
SUPPL-66 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
10/26/2021 |
CUBICIN RF NDA #021572 |
SUPPL-65 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
10/26/2021 |
CUBICIN RF NDA #021572 |
SUPPL-66 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
10/26/2021 |
RIFAMPIN ANDA #204101 |
SUPPL-10 |
RIFAMPIN |
AVET LIFESCIENCES |
Labeling |
Approval |
10/26/2021 |
PIPERACILLIN AND TAZOBACTAM ANDA #207146 |
SUPPL-6 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WOCKHARDT BIO AG |
Labeling |
Approval |
10/26/2021 |
SUCCINYLCHOLINE CHLORIDE ANDA #211625 |
SUPPL-1 |
SUCCINYLCHOLINE CHLORIDE |
UMEDICA |
Labeling |
Approval |
10/26/2021 |
TEPEZZA BLA #761143 |
SUPPL-14 |
TEPROTUMUMAB-TRBW |
HORIZON THERAPEUTICS IRELAND |
|
Approval |
10/27/2021 |
SOLU-MEDROL NDA #011856 |
SUPPL-139 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
PHARMACIA AND UPJOHN |
Manufacturing (CMC) |
Approval |
10/27/2021 |
HALCION NDA #017892 |
SUPPL-56 |
TRIAZOLAM |
PFIZER |
Labeling |
Approval |
10/27/2021 |
ADASUVE NDA #022549 |
SUPPL-9 |
LOXAPINE |
ALEXZA PHARMS |
Labeling |
Approval |
10/27/2021 |
METHOTREXATE SODIUM ANDA #040263 |
SUPPL-14 |
METHOTREXATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
10/27/2021 |
METHOTREXATE SODIUM ANDA #040263 |
SUPPL-18 |
METHOTREXATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
10/27/2021 |
METOCLOPRAMIDE HYDROCHLORIDE ANDA #091392 |
SUPPL-6 |
METOCLOPRAMIDE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
10/27/2021 |
VALSARTAN ANDA #204038 |
ORIG-1 |
VALSARTAN |
SCIEGEN PHARMS INC |
|
Approval |
10/28/2021 |
PHOSPHOLINE IODIDE NDA #011963 |
SUPPL-52 |
ECHOTHIOPHATE IODIDE |
FERA PHARMS LLC |
Labeling |
Approval |
10/28/2021 |
ZARONTIN NDA #012380 |
SUPPL-37 |
ETHOSUXIMIDE |
PARKE DAVIS |
Labeling |
Approval |
10/28/2021 |
STARLIX NDA #021204 |
SUPPL-25 |
NATEGLINIDE |
NOVARTIS |
Labeling |
Approval |
10/28/2021 |
OXYCONTIN NDA #022272 |
SUPPL-47 |
OXYCODONE HYDROCHLORIDE |
PURDUE PHARMA LP |
Labeling |
Approval |
10/28/2021 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #202867 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
10/28/2021 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #202867 |
SUPPL-8 |
MOXIFLOXACIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
10/28/2021 |
ALBUTEROL SULFATE ANDA #209959 |
SUPPL-10 |
ALBUTEROL SULFATE |
CIPLA |
Labeling |
Approval |
10/28/2021 |
GIVLAARI NDA #212194 |
SUPPL-4 |
GIVOSIRAN SODIUM |
ALNYLAM PHARMS INC |
Labeling |
Approval |
10/28/2021 |
PONVORY NDA #213498 |
SUPPL-1 |
PONESIMOD |
VANDA PHARMS INC |
Labeling |
Approval |
10/28/2021 |
VUITY NDA #214028 |
ORIG-1 |
PILOCARPINE HYDROCHLORIDE |
ABBVIE |
Type 5 - New Formulation or New Manufacturer |
Approval |
10/28/2021 |
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% NDA #215252 |
ORIG-1 |
DILTIAZEM HYDROCHLORIDE |
EXELA PHARMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
10/29/2021 |
ACTHAR GEL NDA #008372 |
SUPPL-71 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
10/29/2021 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-71 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
10/29/2021 |
PURIFIED CORTROPHIN GEL NDA #008975 |
SUPPL-8 |
CORTICOTROPIN |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
10/29/2021 |
LAMOTRIGINE ANDA #078625 |
SUPPL-14 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
10/29/2021 |
ZARONTIN ANDA #080258 |
SUPPL-32 |
ETHOSUXIMIDE |
PARKE-DAVIS |
Labeling |
Approval |
10/29/2021 |
ZARONTIN ANDA #080258 |
SUPPL-35 |
ETHOSUXIMIDE |
PARKE-DAVIS |
Labeling |
Approval |
10/29/2021 |
IBUPROFEN AND FAMOTIDINE ANDA #211278 |
ORIG-1 |
FAMOTIDINE; IBUPROFEN |
TEVA PHARMS USA |
|
Approval |
10/29/2021 |
SUCCINYLCHOLINE CHLORIDE ANDA #214308 |
SUPPL-4 |
SUCCINYLCHOLINE CHLORIDE |
ADAPTIS |
Labeling |
Approval |
10/29/2021 |
SCEMBLIX NDA #215358 |
ORIG-1 |
ASCIMINIB HYDROCHLORIDE |
NOVARTIS |
Type 1 - New Molecular Entity |
Approval |
10/29/2021 |
SCEMBLIX NDA #215358 |
ORIG-2 |
ASCIMINIB HYDROCHLORIDE |
NOVARTIS |
Type 1 - New Molecular Entity |
Approval |
10/29/2021 |
BISOPROLOL FUMARATE ANDA #215563 |
ORIG-1 |
BISOPROLOL FUMARATE |
NOVITIUM PHARMA |
|
Approval |