| 11/01/2023 |
CARVEDILOL
ANDA #078217 |
SUPPL-6 |
CARVEDILOL |
LUPIN |
Labeling |
Approval |
| 11/01/2023 |
CARVEDILOL
ANDA #078251 |
SUPPL-19 |
CARVEDILOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 11/01/2023 |
RABEPRAZOLE SODIUM
ANDA #090678 |
SUPPL-13 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 11/01/2023 |
RABEPRAZOLE SODIUM
ANDA #090678 |
SUPPL-14 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 11/01/2023 |
RABEPRAZOLE SODIUM
ANDA #090678 |
SUPPL-16 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 11/01/2023 |
RABEPRAZOLE SODIUM
ANDA #090678 |
SUPPL-18 |
RABEPRAZOLE SODIUM |
LANNETT CO INC |
Labeling |
Approval |
| 11/01/2023 |
ACETYLCYSTEINE
ANDA #205643 |
ORIG-1 |
ACETYLCYSTEINE |
EXELA PHARMA |
|
Approval |
| 11/01/2023 |
DESVENLAFAXINE SUCCINATE
ANDA #210014 |
SUPPL-17 |
DESVENLAFAXINE SUCCINATE |
YICHANG HUMANWELL |
Labeling |
Approval |
| 11/01/2023 |
DAPSONE
ANDA #212657 |
ORIG-1 |
DAPSONE |
PADAGIS ISRAEL |
|
Approval |
| 11/01/2023 |
UZEDY
NDA #213586 |
SUPPL-1 |
RISPERIDONE |
TEVA |
Labeling |
Approval |
| 11/01/2023 |
VOQUEZNA
NDA #215151 |
ORIG-1 |
VONOPRAZAN FUMARATE |
PHATHOM |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
| 11/01/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #215622 |
SUPPL-1 |
VENLAFAXINE HYDROCHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
| 11/01/2023 |
PANTOPRAZOLE SODIUM
ANDA #215860 |
SUPPL-4 |
PANTOPRAZOLE SODIUM |
MEITHEAL |
Labeling |
Approval |
| 11/01/2023 |
ARIPIPRAZOLE
ANDA #216150 |
ORIG-1 |
ARIPIPRAZOLE |
HETERO LABS LTD III |
|
Approval |
| 11/01/2023 |
MIDODRINE HYDROCHLORIDE
ANDA #217271 |
ORIG-1 |
MIDODRINE HYDROCHLORIDE |
MANKIND PHARMA |
|
Approval |
| 11/01/2023 |
SARCLISA
BLA #761113 |
SUPPL-9 |
ISATUXIMAB-IRFC |
SANOFI AVENTIS US |
|
Approval |
| 11/02/2023 |
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
NDA #050638 |
SUPPL-21 |
PENICILLIN G POTASSIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
| 11/02/2023 |
GALANTAMINE HYDROBROMIDE
ANDA #078185 |
SUPPL-8 |
GALANTAMINE HYDROBROMIDE |
HIKMA |
Manufacturing (CMC) |
Approval |
| 11/02/2023 |
TAMSULOSIN HYDROCHLORIDE
ANDA #078801 |
SUPPL-14 |
TAMSULOSIN HYDROCHLORIDE |
SYNTHON PHARMS |
Labeling |
Approval |
| 11/02/2023 |
ROPINIROLE HYDROCHLORIDE
ANDA #078881 |
SUPPL-25 |
ROPINIROLE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 11/02/2023 |
RISPERIDONE
ANDA #091537 |
SUPPL-11 |
RISPERIDONE |
DASH PHARMS |
Labeling |
Approval |
| 11/02/2023 |
RISPERIDONE
ANDA #091537 |
SUPPL-13 |
RISPERIDONE |
DASH PHARMS |
Labeling |
Approval |
| 11/02/2023 |
PROVAYBLUE
NDA #204630 |
SUPPL-22 |
METHYLENE BLUE |
PROVEPHARM SAS |
Labeling |
Approval |
| 11/02/2023 |
NEOSTIGMINE METHYLSULFATE
ANDA #213244 |
ORIG-1 |
NEOSTIGMINE METHYLSULFATE |
EUGIA PHARMA |
|
Approval |
| 11/02/2023 |
BREXPIPRAZOLE
ANDA #213659 |
ORIG-1 |
BREXPIPRAZOLE |
AUROBINDO PHARMA LTD |
|
Approval |
| 11/02/2023 |
FLUPHENAZINE DECANOATE
ANDA #215365 |
ORIG-1 |
FLUPHENAZINE DECANOATE |
MSN |
|
Approval |
| 11/02/2023 |
FLUOROURACIL
ANDA #215612 |
ORIG-1 |
FLUOROURACIL |
ENCUBE |
|
Approval |
| 11/03/2023 |
SANDOSTATIN
NDA #019667 |
SUPPL-76 |
OCTREOTIDE ACETATE |
NOVARTIS |
Labeling |
Approval |
| 11/03/2023 |
CLINDESSE
NDA #050793 |
SUPPL-31 |
CLINDAMYCIN PHOSPHATE |
PADAGIS US |
Labeling |
Approval |
| 11/03/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #090439 |
SUPPL-1 |
VANCOMYCIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 11/03/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #090439 |
SUPPL-2 |
VANCOMYCIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 11/03/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #090439 |
SUPPL-4 |
VANCOMYCIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 11/03/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #090439 |
SUPPL-5 |
VANCOMYCIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 11/03/2023 |
VANCOMYCIN HYDROCHLORIDE
ANDA #090439 |
SUPPL-6 |
VANCOMYCIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 11/03/2023 |
HUMIRA
BLA #125057 |
SUPPL-423 |
ADALIMUMAB |
ABBVIE INC |
|
Approval |
| 11/03/2023 |
RIVAROXABAN
ANDA #208557 |
ORIG-1 |
RIVAROXABAN |
TARO PHARM INDS LTD |
|
Tentative Approval |
| 11/03/2023 |
VITRAKVI
NDA #210861 |
SUPPL-10 |
LAROTRECTINIB SULFATE |
BAYER HLTHCARE |
Labeling |
Approval |
| 11/03/2023 |
VITRAKVI
NDA #211710 |
SUPPL-9 |
LAROTRECTINIB SULFATE |
BAYER HEALTHCARE |
Labeling |
Approval |
| 11/03/2023 |
DOVATO
NDA #211994 |
SUPPL-20 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Manufacturing (CMC) |
Approval |
| 11/03/2023 |
SUGAMMADEX
ANDA #214307 |
ORIG-1 |
SUGAMMADEX |
EUGIA PHARMA SPECLTS |
|
Tentative Approval |
| 11/03/2023 |
METHYLPREDNISOLONE ACETATE
ANDA #216502 |
ORIG-1 |
METHYLPREDNISOLONE ACETATE |
AMNEAL |
|
Approval |
| 11/03/2023 |
ZITUVIMET
NDA #216743 |
ORIG-1 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN |
ZYDUS LIFESCIENCES |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 11/03/2023 |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #217073 |
ORIG-1 |
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE |
OMSAV PHARMA |
|
Approval |
| 11/06/2023 |
IDAMYCIN PFS
NDA #050734 |
SUPPL-31 |
IDARUBICIN HYDROCHLORIDE |
PFIZER |
Manufacturing (CMC) |
Approval |
| 11/06/2023 |
LYNPARZA
NDA #208558 |
SUPPL-28 |
OLAPARIB |
ASTRAZENECA |
Efficacy |
Approval |
| 11/06/2023 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #212558 |
ORIG-1 |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
LUPIN LTD |
|
Tentative Approval |
| 11/06/2023 |
BRIVARACETAM
ANDA #214875 |
ORIG-1 |
BRIVARACETAM |
APOTEX INC |
|
Tentative Approval |
| 11/06/2023 |
FLUPHENAZINE HYDROCHLORIDE
ANDA #216350 |
ORIG-1 |
FLUPHENAZINE HYDROCHLORIDE |
GLENMARK PHARMS LTD |
|
Approval |
| 11/07/2023 |
INDERAL LA
NDA #018553 |
SUPPL-48 |
PROPRANOLOL HYDROCHLORIDE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
| 11/07/2023 |
INDERAL LA
NDA #018553 |
SUPPL-52 |
PROPRANOLOL HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 11/07/2023 |
REYATAZ
NDA #021567 |
SUPPL-48 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 11/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #090404 |
SUPPL-5 |
TRAMADOL HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 11/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #090404 |
SUPPL-6 |
TRAMADOL HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 11/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #090404 |
SUPPL-10 |
TRAMADOL HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 11/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #090404 |
SUPPL-12 |
TRAMADOL HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 11/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #090404 |
SUPPL-14 |
TRAMADOL HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 11/07/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #090404 |
SUPPL-16 |
TRAMADOL HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 11/07/2023 |
KEYTRUDA
BLA #125514 |
SUPPL-148 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 11/07/2023 |
MESALAMINE
ANDA #203286 |
SUPPL-14 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 11/07/2023 |
BALSALAZIDE DISODIUM
ANDA #206336 |
SUPPL-2 |
BALSALAZIDE DISODIUM |
STRIDES PHARMA |
Labeling |
Approval |
| 11/07/2023 |
REYATAZ
NDA #206352 |
SUPPL-10 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 11/07/2023 |
BROMFENAC
ANDA #214340 |
ORIG-1 |
BROMFENAC |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 11/07/2023 |
LIFITEGRAST
ANDA #215063 |
ORIG-1 |
LIFITEGRAST |
EUGIA PHARMA |
|
Approval |
| 11/08/2023 |
DURAMORPH PF
NDA #018565 |
SUPPL-29 |
MORPHINE SULFATE |
HIKMA |
Labeling |
Approval |
| 11/08/2023 |
INFUMORPH
NDA #018565 |
SUPPL-29 |
MORPHINE SULFATE |
HIKMA |
Labeling |
Approval |
| 11/08/2023 |
SUSTIVA
NDA #020972 |
SUPPL-59 |
EFAVIRENZ |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 11/08/2023 |
SUSTIVA
NDA #021360 |
SUPPL-47 |
EFAVIRENZ |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 11/08/2023 |
CIMZIA
BLA #125160 |
SUPPL-309 |
CERTOLIZUMAB PEGOL |
UCB INC |
|
Approval |
| 11/08/2023 |
ZOLEDRONIC ACID
ANDA #202930 |
SUPPL-13 |
ZOLEDRONIC ACID |
GLAND PHARMA LTD |
Manufacturing (CMC) |
Approval |
| 11/08/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #206055 |
SUPPL-2 |
ESOMEPRAZOLE MAGNESIUM |
ZYDUS PHARMS |
Labeling |
Approval |
| 11/08/2023 |
SCEMBLIX
NDA #215358 |
SUPPL-4 |
ASCIMINIB HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 11/08/2023 |
FRUZAQLA
NDA #217564 |
ORIG-1 |
FRUQUINTINIB |
TAKEDA PHARMS USA |
Type 1 - New Molecular Entity |
Approval |
| 11/08/2023 |
BACLOFEN
ANDA #217687 |
ORIG-1 |
BACLOFEN |
MICRO LABS |
|
Approval |
| 11/08/2023 |
ZEPBOUND
NDA #217806 |
ORIG-1 |
TIRZEPATIDE |
ELI LILLY AND CO |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
| 11/08/2023 |
ZEPBOUND (AUTOINJECTOR)
NDA #217806 |
ORIG-1 |
TIRZEPATIDE |
ELI LILLY AND CO |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
| 11/08/2023 |
CEVIMELINE HYDROCHLORIDE
ANDA #218290 |
ORIG-1 |
CEVIMELINE HYDROCHLORIDE |
BIONPHARMA |
|
Approval |
| 11/09/2023 |
CLARITIN-D
NDA #019670 |
SUPPL-36 |
LORATADINE; PSEUDOEPHEDRINE SULFATE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 11/09/2023 |
CLARITIN-D 24 HOUR
NDA #020470 |
SUPPL-52 |
LORATADINE; PSEUDOEPHEDRINE SULFATE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 11/09/2023 |
FLUDEOXYGLUCOSE F18
NDA #021870 |
SUPPL-18 |
FLUDEOXYGLUCOSE F-18 |
FEINSTEIN |
Labeling |
Approval |
| 11/09/2023 |
EXPAREL
NDA #022496 |
SUPPL-44 |
BUPIVACAINE |
PACIRA PHARMS INC |
Efficacy |
Approval |
| 11/09/2023 |
TECHNETIUM TC-99M SULFUR COLLOID KIT
ANDA #213516 |
ORIG-1 |
TECHNETIUM TC-99M SULFUR COLLOID KIT |
JUBILANT |
|
Approval |
| 11/09/2023 |
REZUROCK
NDA #214783 |
SUPPL-3 |
BELUMOSUDIL MESYLATE |
KADMON PHARMS LLC |
Labeling |
Approval |
| 11/09/2023 |
BRIVARACETAM
ANDA #214921 |
ORIG-1 |
BRIVARACETAM |
MSN LABORATORIES PRIVATE LTD |
|
Tentative Approval |
| 11/09/2023 |
BRIVARACETAM
ANDA #214922 |
ORIG-1 |
BRIVARACETAM |
MSN LABS PVT LTD |
|
Tentative Approval |
| 11/09/2023 |
BRIVARACETAM
ANDA #214924 |
ORIG-1 |
BRIVARACETAM |
MSN LABORATORIES PRIVATE LTD |
|
Tentative Approval |
| 11/09/2023 |
DICLOFENAC POTASSIUM
ANDA #215787 |
SUPPL-1 |
DICLOFENAC POTASSIUM |
SENORES PHARMS |
Manufacturing (CMC) |
Approval |
| 11/09/2023 |
ORSERDU
NDA #217639 |
SUPPL-1 |
ELACESTRANT DIHYDROCHLORIDE |
STEMLINE THERAP |
Labeling |
Approval |
| 11/13/2023 |
GONAL-F
BLA #021765 |
SUPPL-51 |
FOLLITROPIN ALFA/BETA |
EMD SERONO |
|
Approval |
| 11/13/2023 |
GONAL-F RFF
BLA #021765 |
SUPPL-51 |
FOLLITROPIN ALFA/BETA |
EMD SERONO |
|
Approval |
| 11/13/2023 |
LACOSAMIDE
ANDA #216670 |
ORIG-1 |
LACOSAMIDE |
APOTEX |
|
Approval |
| 11/14/2023 |
CROMOLYN SODIUM
ANDA #202745 |
SUPPL-2 |
CROMOLYN SODIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-3 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-4 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-5 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-6 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-9 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-10 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
DEFERASIROX
ANDA #209782 |
SUPPL-11 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 11/14/2023 |
RINVOQ
NDA #211675 |
SUPPL-19 |
UPADACITINIB |
ABBVIE |
Labeling |
Approval |
| 11/14/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #211977 |
SUPPL-9 |
ESOMEPRAZOLE MAGNESIUM |
HETERO LABS LTD III |
Labeling |
Approval |
| 11/14/2023 |
PRADAXA
NDA #214358 |
SUPPL-7 |
DABIGATRAN ETEXILATE MESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 11/14/2023 |
ESTRADIOL
ANDA #216524 |
ORIG-1 |
ESTRADIOL |
PADAGIS ISRAEL |
|
Approval |
| 11/14/2023 |
ANGIOTENSIN II
ANDA #216966 |
ORIG-1 |
ANGIOTENSIN II |
GLAND PHARMA LTD |
|
Tentative Approval |
| 11/15/2023 |
FLONASE SENSIMIST ALLERGY RELIEF
NDA #022051 |
SUPPL-21 |
FLUTICASONE FUROATE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 11/15/2023 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #204228 |
SUPPL-14 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 11/15/2023 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #204228 |
SUPPL-19 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 11/15/2023 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #204228 |
SUPPL-21 |
OMEPRAZOLE; SODIUM BICARBONATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 11/15/2023 |
FLONASE ALLERGY RELIEF
NDA #205434 |
SUPPL-15 |
FLUTICASONE PROPIONATE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 11/15/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209735 |
SUPPL-16 |
ESOMEPRAZOLE MAGNESIUM |
SUN PHARM |
Labeling |
Approval |
| 11/15/2023 |
IMCIVREE
NDA #213793 |
SUPPL-5 |
SETMELANOTIDE ACETATE |
RHYTHM |
Labeling |
Approval |
| 11/15/2023 |
DEFENCATH
NDA #214520 |
ORIG-1 |
HEPARIN SODIUM; TAUROLIDINE |
CORMEDIX |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Approval |
| 11/15/2023 |
NALMEFENE HYDROCHLORIDE
ANDA #216007 |
ORIG-1 |
NALMEFENE HYDROCHLORIDE |
CHENGDU SHUODE |
|
Approval |
| 11/15/2023 |
FLUOXETINE HYDROCHLORIDE
ANDA #216232 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
MICRO LABS |
Labeling |
Approval |
| 11/15/2023 |
AUGTYRO
NDA #218213 |
ORIG-1 |
REPOTRECTINIB |
BRISTOL |
Type 1 - New Molecular Entity |
Approval |
| 11/16/2023 |
METHOTREXATE LPF
NDA #011719 |
SUPPL-138 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 11/16/2023 |
METHOTREXATE PRESERVATIVE FREE
NDA #011719 |
SUPPL-138 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 11/16/2023 |
METHOTREXATE SODIUM
NDA #011719 |
SUPPL-138 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 11/16/2023 |
METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719 |
SUPPL-138 |
METHOTREXATE SODIUM |
HOSPIRA |
Labeling |
Approval |
| 11/16/2023 |
COPAXONE
NDA #020622 |
SUPPL-116 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 11/16/2023 |
THYRO-TABS
NDA #021116 |
SUPPL-27 |
LEVOTHYROXINE SODIUM |
ALVOGEN |
Labeling |
Approval |
| 11/16/2023 |
GILENYA
NDA #022527 |
SUPPL-39 |
FINGOLIMOD HYDROCHLORIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 11/16/2023 |
LEVETIRACETAM
ANDA #090876 |
SUPPL-8 |
LEVETIRACETAM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 11/16/2023 |
PANTOPRAZOLE SODIUM
ANDA #090970 |
SUPPL-31 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
| 11/16/2023 |
SIMPONI
BLA #125289 |
SUPPL-153 |
GOLIMUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
| 11/16/2023 |
KEYTRUDA
BLA #125514 |
SUPPL-143 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 11/16/2023 |
LEVETIRACETAM
ANDA #200475 |
SUPPL-11 |
LEVETIRACETAM |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 11/16/2023 |
LEVETIRACETAM
ANDA #202167 |
SUPPL-9 |
LEVETIRACETAM |
DEXCEL |
Labeling |
Approval |
| 11/16/2023 |
LEVETIRACETAM
ANDA #203059 |
SUPPL-27 |
LEVETIRACETAM |
SUN PHARM |
Labeling |
Approval |
| 11/16/2023 |
XTANDI
NDA #203415 |
SUPPL-22 |
ENZALUTAMIDE |
ASTELLAS |
Efficacy |
Approval |
| 11/16/2023 |
JAIMIESS
ANDA #203770 |
SUPPL-4 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 11/16/2023 |
JAIMIESS
ANDA #203770 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 11/16/2023 |
LINEZOLID
ANDA #204764 |
SUPPL-4 |
LINEZOLID |
FRESENIUS KABI USA |
Labeling |
Approval |
| 11/16/2023 |
LINEZOLID
ANDA #204764 |
SUPPL-5 |
LINEZOLID |
FRESENIUS KABI USA |
Labeling |
Approval |
| 11/16/2023 |
LINEZOLID
ANDA #204764 |
SUPPL-8 |
LINEZOLID |
FRESENIUS KABI USA |
Labeling |
Approval |
| 11/16/2023 |
TIROSINT-SOL
NDA #206977 |
SUPPL-10 |
LEVOTHYROXINE SODIUM |
IBSA |
Labeling |
Approval |
| 11/16/2023 |
TIROSINT-SOL
NDA #206977 |
SUPPL-12 |
LEVOTHYROXINE SODIUM |
IBSA |
Labeling |
Approval |
| 11/16/2023 |
TERIPARATIDE
ANDA #208569 |
ORIG-1 |
TERIPARATIDE |
TEVA PHARMS USA |
|
Approval |
| 11/16/2023 |
ARMONAIR DIGIHALER
NDA #208798 |
SUPPL-16 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Labeling |
Approval |
| 11/16/2023 |
ARMONAIR RESPICLICK
NDA #208798 |
SUPPL-16 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Labeling |
Approval |
| 11/16/2023 |
AIRDUO DIGIHALER
NDA #208799 |
SUPPL-26 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
| 11/16/2023 |
AIRDUO RESPICLICK
NDA #208799 |
SUPPL-26 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
| 11/16/2023 |
TERIPARATIDE
ANDA #211097 |
ORIG-1 |
TERIPARATIDE |
APOTEX |
|
Approval |
| 11/16/2023 |
ESTRADIOL
ANDA #211293 |
SUPPL-9 |
ESTRADIOL |
AMNEAL |
Labeling |
Approval |
| 11/16/2023 |
TAZVERIK
NDA #211723 |
SUPPL-4 |
TAZEMETOSTAT HYDROBROMIDE |
EPIZYME INC |
Labeling |
Approval |
| 11/16/2023 |
TURALIO
NDA #211810 |
SUPPL-12 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
Labeling |
Approval |
| 11/16/2023 |
BONSITY
NDA #211939 |
SUPPL-4 |
TERIPARATIDE |
ALVOGEN |
Efficacy |
Approval |
| 11/16/2023 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #212418 |
SUPPL-1 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
ELITE LABS INC |
Labeling |
Approval |
| 11/16/2023 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #212418 |
SUPPL-2 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
ELITE LABS INC |
Labeling |
Approval |
| 11/16/2023 |
XTANDI
NDA #213674 |
SUPPL-10 |
ENZALUTAMIDE |
ASTELLAS |
Efficacy |
Approval |
| 11/16/2023 |
GANIRELIX ACETATE
ANDA #216075 |
ORIG-1 |
GANIRELIX ACETATE |
LUPIN LTD |
|
Approval |
| 11/16/2023 |
TRUQAP
NDA #218197 |
ORIG-1 |
CAPIVASERTIB |
ASTRAZENECA |
Type 1 - New Molecular Entity |
Approval |
| 11/16/2023 |
RYZNEUTA
BLA #761134 |
ORIG-1 |
EFBEMALENOGRASTIM ALFA-VUXW |
EVIVE BIOTECHNOLOGY |
|
Approval |
| 11/16/2023 |
IDACIO
BLA #761255 |
SUPPL-4 |
ADALIMUMAB-AACF |
FRESENIUS KABI USA |
|
Approval |
| 11/16/2023 |
TECVAYLI
BLA #761291 |
SUPPL-5 |
TECLISTAMAB-CQYV |
JANSSEN BIOTECH |
|
Approval |
| 11/16/2023 |
TALVEY
BLA #761342 |
SUPPL-1 |
TALQUETAMAB-TGVS |
JANSSEN BIOTECH |
|
Approval |
| 11/17/2023 |
MONISTAT 3 COMBINATION PACK
NDA #020670 |
SUPPL-41 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 11/17/2023 |
TRELSTAR
NDA #020715 |
SUPPL-47 |
TRIPTORELIN PAMOATE |
VERITY |
Labeling |
Approval |
| 11/17/2023 |
TRELSTAR
NDA #021288 |
SUPPL-42 |
TRIPTORELIN PAMOATE |
VERITY |
Labeling |
Approval |
| 11/17/2023 |
TRELSTAR
NDA #022437 |
SUPPL-22 |
TRIPTORELIN PAMOATE |
VERITY |
Labeling |
Approval |
| 11/17/2023 |
PRADAXA
NDA #022512 |
SUPPL-47 |
DABIGATRAN ETEXILATE MESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 11/17/2023 |
TEMAZEPAM
ANDA #203482 |
SUPPL-16 |
TEMAZEPAM |
AMNEAL PHARMS |
Labeling |
Approval |
| 11/17/2023 |
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
ANDA #215049 |
ORIG-1 |
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM |
ANNORA PHARMA |
|
Approval |
| 11/17/2023 |
TOPIRAMATE
ANDA #217231 |
ORIG-1 |
TOPIRAMATE |
DR REDDYS |
|
Approval |
| 11/18/2023 |
TEMAZEPAM
ANDA #071620 |
SUPPL-45 |
TEMAZEPAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 11/18/2023 |
ALPRAZOLAM
ANDA #074312 |
SUPPL-17 |
ALPRAZOLAM |
HIKMA |
Labeling |
Approval |
| 11/18/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #076003 |
SUPPL-55 |
TRAMADOL HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 11/18/2023 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732 |
SUPPL-12 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
HIKMA |
Labeling |
Approval |
| 11/18/2023 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490 |
SUPPL-10 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 11/18/2023 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200490 |
SUPPL-13 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
Labeling |
Approval |
| 11/19/2023 |
DARUNAVIR
ANDA #202073 |
SUPPL-1 |
DARUNAVIR |
LUPIN LTD |
Labeling |
Approval |
| 11/19/2023 |
DARUNAVIR
ANDA #202073 |
SUPPL-2 |
DARUNAVIR |
LUPIN LTD |
Labeling |
Approval |
| 11/20/2023 |
VIOKACE
BLA #022542 |
SUPPL-10 |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
VIOKACE |
|
Approval |
| 11/20/2023 |
DICLOFENAC POTASSIUM
ANDA #075582 |
SUPPL-7 |
DICLOFENAC POTASSIUM |
CHARTWELL RX |
Labeling |
Approval |
| 11/20/2023 |
CITALOPRAM HYDROBROMIDE
ANDA #077654 |
SUPPL-4 |
CITALOPRAM HYDROBROMIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 11/20/2023 |
TALTZ
BLA #125521 |
SUPPL-31 |
IXEKIZUMAB |
ELI LILLY AND CO |
|
Tentative Approval |
| 11/20/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #205606 |
SUPPL-16 |
ESOMEPRAZOLE MAGNESIUM |
AUROBINDO PHARMA LTD |
Manufacturing (CMC) |
Approval |
| 11/20/2023 |
PITAVASTATIN CALCIUM
ANDA #206029 |
ORIG-1 |
PITAVASTATIN CALCIUM |
LUPIN LTD |
|
Approval |
| 11/20/2023 |
PITAVASTATIN CALCIUM
ANDA #206029 |
SUPPL-1 |
PITAVASTATIN CALCIUM |
LUPIN LTD |
|
Approval |
| 11/20/2023 |
PITAVASTATIN CALCIUM
ANDA #206029 |
SUPPL-2 |
PITAVASTATIN CALCIUM |
LUPIN LTD |
|
Approval |
| 11/20/2023 |
PITAVASTATIN CALCIUM
ANDA #206029 |
SUPPL-3 |
PITAVASTATIN CALCIUM |
LUPIN LTD |
|
Approval |
| 11/20/2023 |
GABAPENTIN
ANDA #208928 |
ORIG-1 |
GABAPENTIN |
IPCA LABS LTD |
|
Approval |
| 11/20/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209339 |
SUPPL-13 |
ESOMEPRAZOLE MAGNESIUM |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
| 11/20/2023 |
FLUOXETINE HYDROCHLORIDE
ANDA #209419 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 11/20/2023 |
FLUOXETINE HYDROCHLORIDE
ANDA #209419 |
SUPPL-3 |
FLUOXETINE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 11/20/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209495 |
SUPPL-1 |
ESOMEPRAZOLE MAGNESIUM |
GLENMARK PHARMS |
Labeling |
Approval |
| 11/20/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209495 |
SUPPL-2 |
ESOMEPRAZOLE MAGNESIUM |
GLENMARK PHARMS |
Labeling |
Approval |
| 11/20/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209495 |
SUPPL-4 |
ESOMEPRAZOLE MAGNESIUM |
GLENMARK PHARMS |
Labeling |
Approval |
| 11/20/2023 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209495 |
SUPPL-7 |
ESOMEPRAZOLE MAGNESIUM |
GLENMARK PHARMS |
Labeling |
Approval |
| 11/20/2023 |
CYCLOPHOSPHAMIDE
NDA #210735 |
SUPPL-2 |
CYCLOPHOSPHAMIDE |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 11/20/2023 |
ESTRADIOL
ANDA #211396 |
SUPPL-4 |
ESTRADIOL |
AMNEAL |
Labeling |
Approval |
| 11/20/2023 |
DAPAGLIFLOZIN
ANDA #211531 |
ORIG-1 |
DAPAGLIFLOZIN |
LUPIN LTD |
|
Tentative Approval |
| 11/20/2023 |
BREXPIPRAZOLE
ANDA #213669 |
ORIG-1 |
BREXPIPRAZOLE |
HETERO LABS LTD V |
|
Approval |
| 11/20/2023 |
ASTEPRO ALLERGY
NDA #213872 |
SUPPL-4 |
AZELASTINE HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 11/20/2023 |
CHILDREN'S ASTEPRO ALLERGY
NDA #213872 |
SUPPL-4 |
AZELASTINE HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 11/20/2023 |
LEVETIRACETAM
ANDA #214673 |
ORIG-1 |
LEVETIRACETAM |
STRIDES PHARMA |
|
Approval |
| 11/20/2023 |
IBUPROFEN AND FAMOTIDINE
ANDA #216814 |
SUPPL-1 |
FAMOTIDINE; IBUPROFEN |
ASCENT PHARMS INC |
Manufacturing (CMC) |
Approval |
| 11/20/2023 |
PROBENECID
ANDA #217020 |
ORIG-1 |
PROBENECID |
RISING |
|
Approval |
| 11/20/2023 |
PROBENECID
ANDA #217020 |
SUPPL-1 |
PROBENECID |
RISING |
|
Approval |
| 11/20/2023 |
BUPIVACAINE HYDROCHLORIDE
ANDA #217792 |
ORIG-1 |
BUPIVACAINE HYDROCHLORIDE |
SOMERSET |
|
Approval |
| 11/21/2023 |
ANECTINE
NDA #008453 |
SUPPL-41 |
SUCCINYLCHOLINE CHLORIDE |
SANDOZ |
Labeling |
Approval |
| 11/21/2023 |
GONAL-F
BLA #020378 |
SUPPL-84 |
FOLLITROPIN ALFA/BETA |
EMD SERONO |
|
Approval |
| 11/21/2023 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040779 |
SUPPL-28 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
AMNEAL PHARMS NY |
Labeling |
Approval |
| 11/21/2023 |
FLUOXETINE HYDROCHLORIDE
ANDA #075465 |
SUPPL-21 |
FLUOXETINE HYDROCHLORIDE |
MARKSANS PHARMA |
Labeling |
Approval |
| 11/21/2023 |
GRANIX
BLA #125294 |
SUPPL-58 |
TBO-FILGRASTIM |
SICOR BIOTECH |
|
Approval |
| 11/21/2023 |
COSENTYX
BLA #125504 |
SUPPL-66 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
| 11/21/2023 |
LEVETIRACETAM
ANDA #201157 |
SUPPL-11 |
LEVETIRACETAM |
PHARM ASSOC |
Labeling |
Approval |
| 11/21/2023 |
BIVALIRUDIN
ANDA #201577 |
SUPPL-3 |
BIVALIRUDIN |
DR REDDYS |
Labeling |
Approval |
| 11/21/2023 |
MONTELUKAST SODIUM
ANDA #202717 |
SUPPL-20 |
MONTELUKAST SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 11/21/2023 |
TRIMETHOBENZAMIDE HYDROCHLORIDE
ANDA #205950 |
ORIG-1 |
TRIMETHOBENZAMIDE HYDROCHLORIDE |
AVET LIFESCIENCES |
|
Approval |
| 11/21/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #209193 |
SUPPL-5 |
VENLAFAXINE HYDROCHLORIDE |
DEXCEL |
Labeling |
Approval |
| 11/21/2023 |
APIXABAN
ANDA #210066 |
ORIG-1 |
APIXABAN |
HETERO LABS LTD V |
|
Approval |
| 11/21/2023 |
TOBRAMYCIN
ANDA #210915 |
SUPPL-1 |
TOBRAMYCIN |
TEVA PHARMS USA |
Labeling |
Approval |
| 11/21/2023 |
LINEZOLID
ANDA #211813 |
SUPPL-2 |
LINEZOLID |
HETERO LABS |
Labeling |
Approval |
| 11/21/2023 |
FLUVOXAMINE MALEATE
ANDA #212182 |
SUPPL-6 |
FLUVOXAMINE MALEATE |
BIONPHARMA |
Labeling |
Approval |
| 11/21/2023 |
ACYCLOVIR
ANDA #212361 |
ORIG-1 |
ACYCLOVIR |
ALEMBIC |
|
Approval |
| 11/21/2023 |
ORLADEYO
NDA #214094 |
SUPPL-2 |
BEROTRALSTAT HYDROCHLORIDE |
BIOCRYST |
Labeling |
Approval |
| 11/21/2023 |
PACLITAXEL
NDA #216338 |
SUPPL-1 |
PACLITAXEL |
TEVA PHARMS INC |
Efficacy |
Approval |
| 11/21/2023 |
VENLAFAXINE HYDROCHLORIDE
ANDA #217390 |
SUPPL-2 |
VENLAFAXINE HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
| 11/21/2023 |
PROGESTERONE
ANDA #217707 |
ORIG-1 |
PROGESTERONE |
ACCORD HLTHCARE |
|
Approval |
| 11/21/2023 |
PROGESTERONE
ANDA #217707 |
SUPPL-1 |
PROGESTERONE |
ACCORD HLTHCARE |
|
Approval |
| 11/21/2023 |
COSENTYX
BLA #761349 |
SUPPL-4 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
| 11/22/2023 |
METROGEL
NDA #021789 |
SUPPL-13 |
METRONIDAZOLE |
GALDERMA LABS LP |
Labeling |
Approval |
| 11/22/2023 |
DIAZEPAM
ANDA #070464 |
SUPPL-8 |
DIAZEPAM |
NUVO PHARM |
Manufacturing (CMC) |
Approval |
| 11/22/2023 |
METOPROLOL TARTRATE
ANDA #077739 |
SUPPL-30 |
METOPROLOL TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 11/22/2023 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-15 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 11/22/2023 |
DIVALPROEX SODIUM
ANDA #078853 |
SUPPL-17 |
DIVALPROEX SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079145 |
SUPPL-7 |
ROSUVASTATIN CALCIUM |
APOTEX |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079145 |
SUPPL-8 |
ROSUVASTATIN CALCIUM |
APOTEX |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079145 |
SUPPL-9 |
ROSUVASTATIN CALCIUM |
APOTEX |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079170 |
SUPPL-12 |
ROSUVASTATIN CALCIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079170 |
SUPPL-13 |
ROSUVASTATIN CALCIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079170 |
SUPPL-16 |
ROSUVASTATIN CALCIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079170 |
SUPPL-19 |
ROSUVASTATIN CALCIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079170 |
SUPPL-21 |
ROSUVASTATIN CALCIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #079171 |
SUPPL-14 |
ROSUVASTATIN CALCIUM |
SANDOZ |
Labeling |
Approval |
| 11/22/2023 |
METRONIDAZOLE
ANDA #203458 |
SUPPL-19 |
METRONIDAZOLE |
UNICHEM |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #205587 |
SUPPL-4 |
ROSUVASTATIN CALCIUM |
LUPIN |
Labeling |
Approval |
| 11/22/2023 |
BROMFENAC SODIUM
ANDA #206027 |
ORIG-1 |
BROMFENAC SODIUM |
LUPIN LTD |
|
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207408 |
SUPPL-15 |
ROSUVASTATIN CALCIUM |
CHANGZHOU PHARM |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207408 |
SUPPL-17 |
ROSUVASTATIN CALCIUM |
CHANGZHOU PHARM |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207408 |
SUPPL-22 |
ROSUVASTATIN CALCIUM |
CHANGZHOU PHARM |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207408 |
SUPPL-24 |
ROSUVASTATIN CALCIUM |
CHANGZHOU PHARM |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207752 |
SUPPL-10 |
ROSUVASTATIN CALCIUM |
BIOCON PHARMA |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207752 |
SUPPL-13 |
ROSUVASTATIN CALCIUM |
BIOCON PHARMA |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207752 |
SUPPL-17 |
ROSUVASTATIN CALCIUM |
BIOCON PHARMA |
Labeling |
Approval |
| 11/22/2023 |
ROSUVASTATIN CALCIUM
ANDA #207752 |
SUPPL-19 |
ROSUVASTATIN CALCIUM |
BIOCON PHARMA |
Labeling |
Approval |
| 11/22/2023 |
CANAGLIFLOZIN
ANDA #211103 |
ORIG-1 |
CANAGLIFLOZIN |
LUPIN |
|
Tentative Approval |
| 11/22/2023 |
PODOFILOX
ANDA #211871 |
ORIG-1 |
PODOFILOX |
PADAGIS US |
|
Approval |
| 11/22/2023 |
PODOFILOX
ANDA #211871 |
SUPPL-1 |
PODOFILOX |
PADAGIS US |
|
Approval |
| 11/22/2023 |
DEFERIPRONE
ANDA #213239 |
SUPPL-6 |
DEFERIPRONE |
HIKMA |
Labeling |
Approval |
| 11/22/2023 |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
ANDA #215469 |
ORIG-1 |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
STRIDES PHARMA |
|
Approval |
| 11/22/2023 |
BRIMONIDINE TARTRATE
ANDA #217846 |
ORIG-1 |
BRIMONIDINE TARTRATE |
MICRO LABS |
|
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #209425 |
SUPPL-1 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #209425 |
SUPPL-2 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #209425 |
SUPPL-3 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #209425 |
SUPPL-4 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #211185 |
SUPPL-1 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #211185 |
SUPPL-2 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #211185 |
SUPPL-4 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
CARFILZOMIB
ANDA #211185 |
SUPPL-5 |
CARFILZOMIB |
APOTEX |
Labeling |
Approval |
| 11/24/2023 |
OSELTAMIVIR PHOSPHATE
ANDA #218009 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
HAINAN POLY |
|
Approval |
| 11/24/2023 |
OSELTAMIVIR PHOSPHATE
ANDA #218009 |
SUPPL-1 |
OSELTAMIVIR PHOSPHATE |
HAINAN POLY |
|
Approval |
| 11/27/2023 |
TRI-SPRINTEC
ANDA #075808 |
SUPPL-43 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR |
Labeling |
Approval |
| 11/27/2023 |
TRI-SPRINTEC
ANDA #075808 |
SUPPL-45 |
ETHINYL ESTRADIOL; NORGESTIMATE |
BARR |
Labeling |
Approval |
| 11/27/2023 |
FLUVOXAMINE MALEATE
ANDA #075902 |
SUPPL-29 |
FLUVOXAMINE MALEATE |
APOTEX |
Labeling |
Approval |
| 11/27/2023 |
METRONIDAZOLE
ANDA #076522 |
SUPPL-11 |
METRONIDAZOLE |
CHARTWELL RX |
Labeling |
Approval |
| 11/27/2023 |
LEVETIRACETAM
ANDA #090981 |
SUPPL-14 |
LEVETIRACETAM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 11/27/2023 |
LEVETIRACETAM
ANDA #091668 |
SUPPL-2 |
LEVETIRACETAM |
SANDOZ |
Labeling |
Approval |
| 11/27/2023 |
MONTELUKAST SODIUM
ANDA #201581 |
SUPPL-10 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 11/27/2023 |
MONTELUKAST SODIUM
ANDA #201582 |
SUPPL-18 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 11/27/2023 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN |
Labeling |
Approval |
| 11/27/2023 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN |
Labeling |
Approval |
| 11/27/2023 |
LINEZOLID
ANDA #206454 |
SUPPL-2 |
LINEZOLID |
HIKMA |
Labeling |
Approval |
| 11/27/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #208708 |
SUPPL-13 |
TRAMADOL HYDROCHLORIDE |
RUBICON |
Manufacturing (CMC) |
Approval |
| 11/27/2023 |
MESALAMINE
ANDA #208953 |
SUPPL-6 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 11/27/2023 |
MESALAMINE
ANDA #208954 |
SUPPL-3 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 11/27/2023 |
ZAFIRLUKAST
ANDA #213163 |
ORIG-1 |
ZAFIRLUKAST |
AUROBINDO PHARMA |
|
Approval |
| 11/27/2023 |
OGSIVEO
NDA #217677 |
ORIG-1 |
NIROGACESTAT HYDROBROMIDE |
SPRINGWORKS |
Type 1 - New Molecular Entity |
Approval |
| 11/28/2023 |
DROXIA
NDA #016295 |
SUPPL-58 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 11/28/2023 |
HYDREA
NDA #016295 |
SUPPL-58 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 11/28/2023 |
LESCOL XL
NDA #021192 |
SUPPL-29 |
FLUVASTATIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 11/28/2023 |
EXPAREL
NDA #022496 |
SUPPL-51 |
BUPIVACAINE |
PACIRA PHARMS INC |
Labeling |
Approval |
| 11/28/2023 |
AZASAN
ANDA #075252 |
SUPPL-23 |
AZATHIOPRINE |
AAIPHARMA LLC |
Labeling |
Approval |
| 11/28/2023 |
DEFEROXAMINE MESYLATE
ANDA #078718 |
SUPPL-9 |
DEFEROXAMINE MESYLATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 11/28/2023 |
FOSPHENYTOIN SODIUM
ANDA #078736 |
SUPPL-12 |
FOSPHENYTOIN SODIUM |
MYLAN LABS LTD |
Labeling |
Approval |
| 11/28/2023 |
FOSPHENYTOIN SODIUM
ANDA #078736 |
SUPPL-14 |
FOSPHENYTOIN SODIUM |
MYLAN LABS LTD |
Labeling |
Approval |
| 11/28/2023 |
OXALIPLATIN
ANDA #078817 |
SUPPL-27 |
OXALIPLATIN |
SANDOZ |
Labeling |
Approval |
| 11/28/2023 |
MYCOPHENOLIC SODIUM
ANDA #091558 |
SUPPL-14 |
MYCOPHENOLIC SODIUM |
APOTEX INC |
Labeling |
Approval |
| 11/28/2023 |
MYCOPHENOLIC SODIUM
ANDA #091558 |
SUPPL-17 |
MYCOPHENOLIC SODIUM |
APOTEX INC |
Labeling |
Approval |
| 11/28/2023 |
MYCOPHENOLIC SODIUM
ANDA #091558 |
SUPPL-19 |
MYCOPHENOLIC SODIUM |
APOTEX INC |
Labeling |
Approval |
| 11/28/2023 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #201072 |
SUPPL-8 |
DEXMEDETOMIDINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 11/28/2023 |
TIGECYCLINE
ANDA #205722 |
SUPPL-3 |
TIGECYCLINE |
XELLIA PHARMS APS |
Labeling |
Approval |
| 11/28/2023 |
TIGECYCLINE
ANDA #205722 |
SUPPL-4 |
TIGECYCLINE |
XELLIA PHARMS APS |
Labeling |
Approval |
| 11/28/2023 |
FEBUXOSTAT
ANDA #206266 |
SUPPL-2 |
FEBUXOSTAT |
PRINSTON INC |
Labeling |
Approval |
| 11/28/2023 |
FEBUXOSTAT
ANDA #206266 |
SUPPL-3 |
FEBUXOSTAT |
PRINSTON INC |
Labeling |
Approval |
| 11/28/2023 |
DARUNAVIR
ANDA #206288 |
ORIG-1 |
DARUNAVIR |
CIPLA |
|
Approval |
| 11/28/2023 |
DARUNAVIR
ANDA #206288 |
ORIG-2 |
DARUNAVIR |
CIPLA |
|
Tentative Approval |
| 11/28/2023 |
BROMFENAC
ANDA #207334 |
ORIG-1 |
BROMFENAC |
APOTEX INC |
|
Tentative Approval |
| 11/28/2023 |
ABIRATERONE ACETATE
ANDA #208380 |
SUPPL-4 |
ABIRATERONE ACETATE |
WOCKHARDT BIO AG |
Labeling |
Approval |
| 11/28/2023 |
SIKLOS
NDA #208843 |
SUPPL-4 |
HYDROXYUREA |
THERAVIA |
Labeling |
Approval |
| 11/28/2023 |
BIMATOPROST
ANDA #210515 |
SUPPL-2 |
BIMATOPROST |
ALEMBIC |
Labeling |
Approval |
| 11/28/2023 |
BIMATOPROST
ANDA #210515 |
SUPPL-3 |
BIMATOPROST |
ALEMBIC |
Labeling |
Approval |
| 11/28/2023 |
DARUNAVIR
ANDA #210677 |
ORIG-1 |
DARUNAVIR |
AUROBINDO PHARMA LTD |
|
Approval |
| 11/28/2023 |
ICATIBANT ACETATE
ANDA #211021 |
SUPPL-6 |
ICATIBANT ACETATE |
JIANGSU HANSOH PHARM |
Labeling |
Approval |
| 11/28/2023 |
URSODIOL
ANDA #211145 |
SUPPL-1 |
URSODIOL |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 11/28/2023 |
URSODIOL
ANDA #211145 |
SUPPL-2 |
URSODIOL |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 11/28/2023 |
DARUNAVIR
ANDA #211578 |
ORIG-1 |
DARUNAVIR |
DR REDDYS |
|
Approval |
| 11/28/2023 |
BREXPIPRAZOLE
ANDA #213782 |
ORIG-1 |
BREXPIPRAZOLE |
ALKEM LABS LTD |
|
Approval |
| 11/28/2023 |
TRIAZOLAM
ANDA #214219 |
SUPPL-5 |
TRIAZOLAM |
NOVAST LABS |
Labeling |
Approval |
| 11/28/2023 |
DARUNAVIR
ANDA #215389 |
ORIG-1 |
DARUNAVIR |
MSN |
|
Approval |
| 11/28/2023 |
RYZUMVI
NDA #217064 |
SUPPL-1 |
PHENTOLAMINE MESYLATE |
FAMYGEN LIFE SCI |
Labeling |
Approval |
| 11/28/2023 |
AZILSARTAN MEDOXOMIL; CHLORTHALIDONE
ANDA #217490 |
ORIG-1 |
AZILSARTAN MEDOXOMIL;CHLORTHALIDONE |
ALKEM LABS LTD |
|
Tentative Approval |
| 11/28/2023 |
SILDENAFIL CITRATE
ANDA #218045 |
ORIG-1 |
SILDENAFIL CITRATE |
CADILA PHARMS LTD |
|
Approval |
| 11/29/2023 |
VOLTAREN ARTHRITIS PAIN
NDA #022122 |
SUPPL-25 |
DICLOFENAC SODIUM |
HALEON US HOLDINGS |
Labeling |
Approval |
| 11/29/2023 |
MIRTAZAPINE
ANDA #076176 |
SUPPL-10 |
MIRTAZAPINE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 11/29/2023 |
OXALIPLATIN
ANDA #078803 |
SUPPL-7 |
OXALIPLATIN |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 11/29/2023 |
NEVIRAPINE
ANDA #206448 |
SUPPL-6 |
NEVIRAPINE |
CIPLA |
Labeling |
Approval |
| 11/29/2023 |
CLARISCAN
ANDA #210016 |
SUPPL-7 |
GADOTERATE MEGLUMINE |
GE HEALTHCARE |
Labeling |
Approval |
| 11/29/2023 |
FEBUXOSTAT
ANDA #210292 |
SUPPL-5 |
FEBUXOSTAT |
INDOCO |
Labeling |
Approval |
| 11/29/2023 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #210374 |
ORIG-1 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
DEVA HOLDING AS |
|
Approval |
| 11/29/2023 |
HYDROXYCHLOROQUINE SULFATE
ANDA #210441 |
SUPPL-13 |
HYDROXYCHLOROQUINE SULFATE |
APPCO |
Labeling |
Approval |
| 11/29/2023 |
CLOBETASOL PROPIONATE
ANDA #210809 |
SUPPL-1 |
CLOBETASOL PROPIONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 11/29/2023 |
CLOBETASOL PROPIONATE
ANDA #210809 |
SUPPL-2 |
CLOBETASOL PROPIONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 11/29/2023 |
CLOBETASOL PROPIONATE
ANDA #210809 |
SUPPL-4 |
CLOBETASOL PROPIONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 11/29/2023 |
BRINZOLAMIDE; BRIMONIDINE TARTRATE
ANDA #212137 |
ORIG-1 |
BRINZOLAMIDE;BRIMONIDINE TARTRATE |
PERRIGO PHARMA INTERNATIONAL DAC |
|
Tentative Approval |
| 11/29/2023 |
IVABRADINE HYDROCHLORIDE
ANDA #213442 |
ORIG-1 |
IVABRADINE HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 11/29/2023 |
PANTOPRAZOLE SODIUM
ANDA #213725 |
SUPPL-6 |
PANTOPRAZOLE SODIUM |
SUN PHARM |
Labeling |
Approval |
| 11/29/2023 |
LOTEPREDNOL ETABONATE
ANDA #213956 |
ORIG-1 |
LOTEPREDNOL ETABONATE |
HIKMA |
|
Approval |
| 11/29/2023 |
FOSCARNET SODIUM
ANDA #213987 |
ORIG-1 |
FOSCARNET SODIUM |
BEIJING |
|
Approval |
| 11/29/2023 |
AZELASTINE HYDROCHLORIDE
ANDA #216561 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
|
Tentative Approval |
| 11/29/2023 |
BUDESONIDE
ANDA #216667 |
ORIG-1 |
BUDESONIDE |
EUGIA PHARMA |
|
Approval |
| 11/29/2023 |
ALVAIZ
NDA #216774 |
ORIG-1 |
ELTROMBOPAG CHOLINE |
TEVA PHARMS INC |
Type 2 - New Active Ingredient |
Approval |
| 11/29/2023 |
MYCOPHENOLIC SODIUM
ANDA #217031 |
ORIG-1 |
MYCOPHENOLIC SODIUM |
SKG PHARMA |
|
Approval |
| 11/29/2023 |
ASPARLAS
BLA #761102 |
SUPPL-13 |
CALASPARGASE PEGOL-MKNL |
SERVIER PHARMA LLC |
|
Approval |
| 11/29/2023 |
SEMGLEE
BLA #761201 |
SUPPL-8 |
INSULIN GLARGINE-YFGN |
MYLAN PHARMS INC |
|
Approval |
| 11/30/2023 |
SODIUM PHOSPHATES IN PLASTIC CONTAINER
NDA #018892 |
SUPPL-38 |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 11/30/2023 |
CONTRAVE
NDA #200063 |
SUPPL-21 |
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE |
NALPROPION |
Labeling |
Approval |
| 11/30/2023 |
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
NDA #205054 |
SUPPL-5 |
LEUPROLIDE ACETATE |
INVAGEN PHARMS |
Labeling |
Approval |
| 11/30/2023 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #211610 |
SUPPL-1 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
WES PHARMA INC |
Labeling |
Approval |
| 11/30/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #211825 |
SUPPL-5 |
TRAMADOL HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 11/30/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #211825 |
SUPPL-8 |
TRAMADOL HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 11/30/2023 |
TRAMADOL HYDROCHLORIDE
ANDA #211825 |
SUPPL-12 |
TRAMADOL HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 11/30/2023 |
SYFOVRE
NDA #217171 |
SUPPL-1 |
PEGCETACOPLAN |
APELLIS PHARMS |
Labeling |
Approval |
| 11/30/2023 |
YUFLYMA
BLA #761219 |
SUPPL-2 |
ADALIMUMAB-AATY |
CELLTRION |
|
Approval |
