| 09/03/2024 |
LINAGLIPTIN
ANDA #208423 |
ORIG-1 |
LINAGLIPTIN |
INVAGEN PHARMS |
|
Approval |
| 09/03/2024 |
ICATIBANT ACETATE
ANDA #210118 |
SUPPL-6 |
ICATIBANT ACETATE |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 09/03/2024 |
IBUPROFEN
ANDA #215311 |
SUPPL-1 |
IBUPROFEN |
STRIDES PHARMA |
Manufacturing (CMC) |
Approval |
| 09/04/2024 |
TRILEPTAL
NDA #021014 |
SUPPL-50 |
OXCARBAZEPINE |
NOVARTIS |
Labeling |
Approval |
| 09/04/2024 |
TRILEPTAL
NDA #021285 |
SUPPL-42 |
OXCARBAZEPINE |
NOVARTIS |
Labeling |
Approval |
| 09/04/2024 |
CASPOFUNGIN ACETATE
ANDA #200833 |
SUPPL-7 |
CASPOFUNGIN ACETATE |
HENGRUI PHARMA |
Labeling |
Approval |
| 09/04/2024 |
DESVENLAFAXINE SUCCINATE
ANDA #204082 |
SUPPL-7 |
DESVENLAFAXINE SUCCINATE |
HIKMA |
Labeling |
Approval |
| 09/04/2024 |
DESVENLAFAXINE SUCCINATE
ANDA #204082 |
SUPPL-8 |
DESVENLAFAXINE SUCCINATE |
HIKMA |
Labeling |
Approval |
| 09/04/2024 |
DESVENLAFAXINE SUCCINATE
ANDA #204082 |
SUPPL-11 |
DESVENLAFAXINE SUCCINATE |
HIKMA |
Labeling |
Approval |
| 09/04/2024 |
DESVENLAFAXINE SUCCINATE
ANDA #204083 |
SUPPL-6 |
DESVENLAFAXINE SUCCINATE |
HIKMA |
Labeling |
Approval |
| 09/04/2024 |
DESVENLAFAXINE SUCCINATE
ANDA #204083 |
SUPPL-7 |
DESVENLAFAXINE SUCCINATE |
HIKMA |
Labeling |
Approval |
| 09/04/2024 |
DESVENLAFAXINE SUCCINATE
ANDA #204083 |
SUPPL-10 |
DESVENLAFAXINE SUCCINATE |
HIKMA |
Labeling |
Approval |
| 09/04/2024 |
EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212375 |
ORIG-1 |
EMPAGLIFLOZIN;LINAGLIPTIN |
MACLEODS PHARMS LTD |
|
Tentative Approval |
| 09/04/2024 |
LACOSAMIDE
ANDA #213109 |
ORIG-1 |
LACOSAMIDE |
UNICHEM |
|
Approval |
| 09/04/2024 |
ALBENDAZOLE
ANDA #215652 |
ORIG-1 |
ALBENDAZOLE |
ALEMBIC |
|
Approval |
| 09/05/2024 |
CYTOXAN
NDA #012142 |
SUPPL-116 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/05/2024 |
CYTOXAN (LYOPHILIZED)
NDA #012142 |
SUPPL-116 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/05/2024 |
LYOPHILIZED CYTOXAN
NDA #012142 |
SUPPL-116 |
CYCLOPHOSPHAMIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/05/2024 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040104 |
SUPPL-36 |
HYDROXYCHLOROQUINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 09/05/2024 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040104 |
SUPPL-37 |
HYDROXYCHLOROQUINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 09/05/2024 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040104 |
SUPPL-38 |
HYDROXYCHLOROQUINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 09/05/2024 |
TICAGRELOR
ANDA #208597 |
SUPPL-1 |
TICAGRELOR |
MYLAN |
Labeling |
Approval |
| 09/05/2024 |
TICAGRELOR
ANDA #208597 |
SUPPL-2 |
TICAGRELOR |
MYLAN |
Labeling |
Approval |
| 09/05/2024 |
ZILRETTA
NDA #208845 |
SUPPL-19 |
TRIAMCINOLONE ACETONIDE |
PACIRA PHARMS INC |
Labeling |
Approval |
| 09/05/2024 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
ANDA #209061 |
ORIG-1 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MYLAN |
|
Approval |
| 09/05/2024 |
LUCEMYRA
NDA #209229 |
SUPPL-7 |
LOFEXIDINE HYDROCHLORIDE |
USWM |
Labeling |
Approval |
| 09/05/2024 |
IVABRADINE HYDROCHLORIDE
ANDA #213276 |
ORIG-1 |
IVABRADINE HYDROCHLORIDE |
BIONPHARMA |
|
Approval |
| 09/05/2024 |
BOSENTAN
ANDA #213981 |
ORIG-1 |
BOSENTAN |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
| 09/05/2024 |
HYDROCORTISONE SODIUM SUCCINATE
ANDA #214050 |
ORIG-1 |
HYDROCORTISONE SODIUM SUCCINATE |
CIPLA |
|
Approval |
| 09/05/2024 |
TENOFOVIR ALAFENAMIDE
ANDA #214179 |
ORIG-1 |
TENOFOVIR ALAFENAMIDE |
HETERO LABS LTD V |
|
Tentative Approval |
| 09/05/2024 |
HYDROCORTISONE
ANDA #214649 |
SUPPL-2 |
HYDROCORTISONE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 09/05/2024 |
THEOPHYLLINE
ANDA #215312 |
ORIG-1 |
THEOPHYLLINE |
STRIDES PHARMA |
|
Approval |
| 09/05/2024 |
FILSPARI
NDA #216403 |
SUPPL-3 |
SPARSENTAN |
TRAVERE |
Efficacy |
Approval |
| 09/05/2024 |
NELARABINE
ANDA #216510 |
ORIG-1 |
NELARABINE |
XGEN PHARMS |
|
Approval |
| 09/05/2024 |
TYENNE
BLA #761275 |
SUPPL-1 |
TOCILIZUMAB-AAZG |
FRESENIUS KABI USA |
|
Approval |
| 09/06/2024 |
NICORETTE
NDA #021330 |
SUPPL-26 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
| 09/06/2024 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071588 |
SUPPL-34 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 09/06/2024 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071601 |
SUPPL-35 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 09/06/2024 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071602 |
SUPPL-32 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 09/06/2024 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071766 |
SUPPL-33 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 09/06/2024 |
DESIPRAMINE HYDROCHLORIDE
ANDA #074430 |
SUPPL-22 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 09/06/2024 |
BEXAROTENE
ANDA #208628 |
ORIG-1 |
BEXAROTENE |
ASCENT PHARMS INC |
|
Approval |
| 09/06/2024 |
POTASSIUM CHLORIDE
ANDA #212987 |
ORIG-1 |
POTASSIUM CHLORIDE |
MACLEODS PHARMS LTD |
|
Approval |
| 09/06/2024 |
EPINEPHRINE
ANDA #217192 |
ORIG-1 |
EPINEPHRINE |
AM REGENT |
|
Approval |
| 09/06/2024 |
NICARDIPINE HYDROCHLORIDE
ANDA #217548 |
ORIG-1 |
NICARDIPINE HYDROCHLORIDE |
CHENGDU SHUODE |
|
Approval |
| 09/06/2024 |
HERCESSI
BLA #761346 |
SUPPL-1 |
TRASTUZUMAB-STRF |
ACCORD BIOPHARMA INC. |
|
Approval |
| 09/09/2024 |
ADVIL PM
NDA #021393 |
SUPPL-22 |
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 09/09/2024 |
VERAPAMIL HYDROCHLORIDE
ANDA #070737 |
SUPPL-28 |
VERAPAMIL HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/09/2024 |
LEVOFLOXACIN
ANDA #076361 |
SUPPL-16 |
LEVOFLOXACIN |
TEVA |
Labeling |
Approval |
| 09/09/2024 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078024 |
SUPPL-31 |
CIPROFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 09/09/2024 |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078024 |
SUPPL-35 |
CIPROFLOXACIN |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 09/09/2024 |
RISPERIDONE
ANDA #091384 |
SUPPL-13 |
RISPERIDONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 09/09/2024 |
CHOLINE C-11
NDA #203155 |
SUPPL-9 |
CHOLINE C-11 |
MCPRF |
Labeling |
Approval |
| 09/09/2024 |
GABAPENTIN
ANDA #203643 |
ORIG-1 |
GABAPENTIN |
INCEPTA PHARMS LTD |
|
Approval |
| 09/09/2024 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534 |
SUPPL-1 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 09/09/2024 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534 |
SUPPL-2 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 09/09/2024 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 09/09/2024 |
GABAPENTIN
ANDA #207099 |
SUPPL-18 |
GABAPENTIN |
RISING PHARMA |
Labeling |
Approval |
| 09/09/2024 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #211594 |
SUPPL-1 |
BUPRENORPHINE HYDROCHLORIDE |
ALVOGEN |
Labeling |
Approval |
| 09/09/2024 |
LINAGLIPTIN
ANDA #217749 |
ORIG-1 |
LINAGLIPTIN |
HETERO LABS LTD |
|
Tentative Approval |
| 09/09/2024 |
CABERGOLINE
ANDA #218109 |
ORIG-1 |
CABERGOLINE |
WELDING |
|
Approval |
| 09/10/2024 |
ESTRASORB
NDA #021371 |
SUPPL-9 |
ESTRADIOL HEMIHYDRATE |
EXELTIS USA INC |
Labeling |
Approval |
| 09/10/2024 |
LEVOFLOXACIN
ANDA #077097 |
SUPPL-10 |
LEVOFLOXACIN |
NATCO PHARMA |
Labeling |
Approval |
| 09/10/2024 |
ESTRADIOL
ANDA #204379 |
SUPPL-1 |
ESTRADIOL |
ZYDUS PHARMS |
Labeling |
Approval |
| 09/10/2024 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #206931 |
SUPPL-10 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
ABHAI INC |
Labeling |
Approval |
| 09/10/2024 |
TOPIRAMATE
ANDA #207382 |
SUPPL-9 |
TOPIRAMATE |
ZYDUS |
Manufacturing (CMC) |
Approval |
| 09/10/2024 |
LEVOTHYROXINE SODIUM
ANDA #207588 |
SUPPL-6 |
LEVOTHYROXINE SODIUM |
WATSON LABS TEVA |
Labeling |
Approval |
| 09/10/2024 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #209211 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CEDIPROF INC |
Labeling |
Approval |
| 09/10/2024 |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #210507 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
UNICHEM |
|
Approval |
| 09/10/2024 |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA #216114 |
ORIG-1 |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOMERSET |
|
Approval |
| 09/10/2024 |
ELREXFIO
BLA #761345 |
SUPPL-2 |
ELRANATAMAB |
PFIZER INC |
|
Approval |
| 09/11/2024 |
ALEVE
NDA #020204 |
SUPPL-88 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
| 09/11/2024 |
DABIGATRAN ETEXILATE MESYLATE
ANDA #208040 |
ORIG-2 |
DABIGATRAN ETEXILATE MESYLATE |
ALKEM LABS LTD |
|
Approval |
| 09/11/2024 |
VUMERITY
NDA #211855 |
SUPPL-17 |
DIROXIMEL FUMARATE |
BIOGEN INC |
Manufacturing (CMC) |
Approval |
| 09/11/2024 |
BUSULFAN
ANDA #215235 |
ORIG-1 |
BUSULFAN |
PRINSTON INC |
|
Approval |
| 09/11/2024 |
LENALIDOMIDE
ANDA #217281 |
ORIG-1 |
LENALIDOMIDE |
NOVUGEN |
|
Approval |
| 09/11/2024 |
AMIODARONE HYDROCHLORIDE
ANDA #218253 |
ORIG-1 |
AMIODARONE HYDROCHLORIDE |
ZHEJIANG POLY PHARM |
|
Approval |
| 09/11/2024 |
TREMFYA
BLA #761061 |
SUPPL-21 |
GUSELKUMAB |
JANSSEN BIOTECH |
|
Approval |
| 09/12/2024 |
CLOZARIL
NDA #019758 |
SUPPL-104 |
CLOZAPINE |
HERITAGE LIFE |
Labeling |
Approval |
| 09/12/2024 |
SABRIL
NDA #020427 |
SUPPL-27 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
REMS |
Approval |
| 09/12/2024 |
ZYRTEC-D 12 HOUR
NDA #021150 |
SUPPL-22 |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Labeling |
Approval |
| 09/12/2024 |
SABRIL
NDA #022006 |
SUPPL-28 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
REMS |
Approval |
| 09/12/2024 |
INVEGA SUSTENNA
NDA #022264 |
SUPPL-37 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 09/12/2024 |
DILTIAZEM HYDROCHLORIDE
ANDA #074910 |
SUPPL-19 |
DILTIAZEM HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 09/12/2024 |
DICLOFENAC SODIUM
ANDA #075910 |
SUPPL-30 |
DICLOFENAC SODIUM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 09/12/2024 |
DICLOFENAC SODIUM
ANDA #076152 |
SUPPL-15 |
DICLOFENAC SODIUM |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 09/12/2024 |
CIPROFLOXACIN EXTENDED RELEASE
ANDA #077809 |
SUPPL-9 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 09/12/2024 |
CIPROFLOXACIN EXTENDED RELEASE
ANDA #078166 |
SUPPL-16 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 09/12/2024 |
CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183 |
SUPPL-22 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
RISING PHARMA |
Labeling |
Approval |
| 09/12/2024 |
CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183 |
SUPPL-24 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
RISING PHARMA |
Labeling |
Approval |
| 09/12/2024 |
GEMCITABINE HYDROCHLORIDE
ANDA #090242 |
SUPPL-4 |
GEMCITABINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 09/12/2024 |
ENBREL
BLA #103795 |
SUPPL-5600 |
ETANERCEPT |
IMMUNEX |
|
Approval |
| 09/12/2024 |
NAGLAZYME
BLA #125117 |
SUPPL-132 |
GALSULFASE |
BIOMARIN |
|
Approval |
| 09/12/2024 |
INVEGA HAFYERA
NDA #207946 |
SUPPL-14 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 09/12/2024 |
INVEGA HAFYERA
NDA #207946 |
SUPPL-15 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 09/12/2024 |
INVEGA TRINZA
NDA #207946 |
SUPPL-14 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 09/12/2024 |
INVEGA TRINZA
NDA #207946 |
SUPPL-15 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #208218 |
SUPPL-15 |
VIGABATRIN |
ENDO OPERATIONS |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #209822 |
SUPPL-12 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #209824 |
SUPPL-13 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #210042 |
SUPPL-6 |
VIGABATRIN |
AMNEAL PHARMS |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #210155 |
SUPPL-19 |
VIGABATRIN |
AMNEAL PHARMS |
REMS |
Approval |
| 09/12/2024 |
VIGADRONE
ANDA #210196 |
SUPPL-20 |
VIGABATRIN |
AUCTA |
REMS |
Approval |
| 09/12/2024 |
TICAGRELOR
ANDA #210219 |
ORIG-1 |
TICAGRELOR |
ALKEM LABS LTD |
|
Tentative Approval |
| 09/12/2024 |
BRAFTOVI
NDA #210496 |
SUPPL-16 |
ENCORAFENIB |
ARRAY BIOPHARMA INC |
Efficacy |
Approval |
| 09/12/2024 |
MEKTOVI
NDA #210498 |
SUPPL-10 |
BINIMETINIB |
ARRAY BIOPHARMA INC |
Efficacy |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #211481 |
SUPPL-9 |
VIGABATRIN |
DR REDDYS |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #211539 |
SUPPL-2 |
VIGABATRIN |
DR REDDYS |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #211592 |
SUPPL-9 |
VIGABATRIN |
INVAGEN PHARMS |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #213104 |
SUPPL-2 |
VIGABATRIN |
HIKMA |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #213375 |
SUPPL-5 |
VIGABATRIN |
ALKEM LABS LTD |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #213390 |
SUPPL-3 |
VIGABATRIN |
PROPEL PHARMA |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #213469 |
SUPPL-5 |
VIGABATRIN |
GRANULES |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #213519 |
SUPPL-4 |
VIGABATRIN |
ANNORA PHARMA |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #213899 |
SUPPL-4 |
VIGABATRIN |
AUROBINDO PHARMA LTD |
REMS |
Approval |
| 09/12/2024 |
METHOTREXATE
NDA #214121 |
SUPPL-3 |
METHOTREXATE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #214425 |
SUPPL-4 |
VIGABATRIN |
ACCORD HLTHCARE |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #214671 |
SUPPL-1 |
VIGABATRIN |
ZYDUS LIFESCIENCES |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #214749 |
SUPPL-1 |
VIGABATRIN |
UPSHER SMITH LABS |
REMS |
Approval |
| 09/12/2024 |
VIGPODER
ANDA #214961 |
SUPPL-7 |
VIGABATRIN |
PYROS PHARMS |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #214992 |
SUPPL-3 |
VIGABATRIN |
DEXCEL |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #215109 |
SUPPL-3 |
VIGABATRIN |
DEXCEL |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #215363 |
SUPPL-2 |
VIGABATRIN |
MSN |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #215519 |
SUPPL-1 |
VIGABATRIN |
PROPEL PHARMA |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #215601 |
SUPPL-3 |
VIGABATRIN |
AUROBINDO PHARMA LTD |
REMS |
Approval |
| 09/12/2024 |
VIGABATRIN
ANDA #215707 |
SUPPL-3 |
VIGABATRIN |
ZYDUS LIFESCIENCES |
REMS |
Approval |
| 09/12/2024 |
PAXLOVID (COPACKAGED)
NDA #217188 |
SUPPL-6 |
NIRMATRELVIR; RITONAVIR |
PFIZER |
Labeling |
Approval |
| 09/12/2024 |
VIGAFYDE
NDA #217684 |
SUPPL-1 |
VIGABATRIN |
PYROS PHARMS |
REMS |
Approval |
| 09/12/2024 |
CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #218936 |
ORIG-1 |
CYCLOBENZAPRINE HYDROCHLORIDE |
GRAVITI PHARMS |
|
Approval |
| 09/12/2024 |
DUPIXENT
BLA #761055 |
SUPPL-66 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 09/12/2024 |
TECENTRIQ HYBREZA
NDA #761347 |
ORIG-1 |
ATEZOLIZUMAB;HYALURONIDASE-TQJS |
GENENTECH INC |
Type 3 - New Dosage Form |
Approval |
| 09/13/2024 |
QSYMIA
NDA #022580 |
SUPPL-25 |
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
VIVUS LLC |
Efficacy |
Approval |
| 09/13/2024 |
CIMZIA
BLA #125160 |
SUPPL-275 |
CERTOLIZUMAB PEGOL |
UCB INC |
|
Approval |
| 09/13/2024 |
ERLOTINIB HYDROCHLORIDE
ANDA #203843 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
HIKMA |
|
Approval |
| 09/13/2024 |
PROCHLORPERAZINE EDISYLATE
ANDA #212257 |
ORIG-1 |
PROCHLORPERAZINE EDISYLATE |
SOMERSET THERAPS LLC |
|
Approval |
| 09/13/2024 |
FLUOXETINE HYDROCHLORIDE
ANDA #212683 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
| 09/13/2024 |
NELARABINE
ANDA #216948 |
ORIG-1 |
NELARABINE |
MSN |
|
Approval |
| 09/13/2024 |
EBGLYSS
BLA #761306 |
ORIG-1 |
LEBRIKIZUMAB-LBKZ |
ELI LILLY AND CO |
|
Approval |
| 09/13/2024 |
OCREVUS ZUNOVO
BLA #761371 |
ORIG-1 |
OCRELIZUMAB;HYALURONIDASE-OCSQ |
GENENTECH INC |
|
Approval |
| 09/16/2024 |
CHEMET
NDA #019998 |
SUPPL-23 |
SUCCIMER |
RECORDATI RARE |
Labeling |
Approval |
| 09/16/2024 |
SANCUSO
NDA #022198 |
SUPPL-23 |
GRANISETRON |
CUMBERLAND |
Labeling |
Approval |
| 09/16/2024 |
ZYCLARA
NDA #022483 |
SUPPL-11 |
IMIQUIMOD |
BAUSCH |
Labeling |
Approval |
| 09/16/2024 |
MEDROXYPROGESTERONE ACETATE
ANDA #040159 |
SUPPL-34 |
MEDROXYPROGESTERONE ACETATE |
BARR |
Labeling |
Approval |
| 09/16/2024 |
BUPROPION HYDROCHLORIDE
ANDA #077285 |
SUPPL-42 |
BUPROPION HYDROCHLORIDE |
WATSON LABS INC |
Labeling |
Approval |
| 09/16/2024 |
BUPROPION HYDROCHLORIDE
ANDA #077285 |
SUPPL-45 |
BUPROPION HYDROCHLORIDE |
WATSON LABS INC |
Labeling |
Approval |
| 09/16/2024 |
LEVETIRACETAM
ANDA #090992 |
SUPPL-11 |
LEVETIRACETAM |
AMNEAL PHARMS |
Labeling |
Approval |
| 09/16/2024 |
LANSOPRAZOLE
ANDA #200816 |
SUPPL-4 |
LANSOPRAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
| 09/16/2024 |
LEVOFLOXACIN
ANDA #200839 |
SUPPL-31 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 09/16/2024 |
LEVOFLOXACIN
ANDA #200839 |
SUPPL-33 |
LEVOFLOXACIN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 09/16/2024 |
LISDEXAMFETAMINE DIMESYLATE
ANDA #202802 |
SUPPL-2 |
LISDEXAMFETAMINE DIMESYLATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 09/16/2024 |
LISDEXAMFETAMINE DIMESYLATE
ANDA #202830 |
SUPPL-2 |
LISDEXAMFETAMINE DIMESYLATE |
AMNEAL |
Labeling |
Approval |
| 09/16/2024 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436 |
SUPPL-2 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MYLAN |
Labeling |
Approval |
| 09/16/2024 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436 |
SUPPL-4 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MYLAN |
Labeling |
Approval |
| 09/16/2024 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436 |
SUPPL-7 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MYLAN |
Labeling |
Approval |
| 09/16/2024 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436 |
SUPPL-8 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MYLAN |
Labeling |
Approval |
| 09/16/2024 |
CLOBAZAM
ANDA #210039 |
SUPPL-9 |
CLOBAZAM |
AMNEAL |
Labeling |
Approval |
| 09/16/2024 |
TIMOLOL MALEATE
ANDA #210640 |
ORIG-1 |
TIMOLOL MALEATE |
SOMERSET THERAPS LLC |
|
Approval |
| 09/16/2024 |
FOSAPREPITANT DIMEGLUMINE
ANDA #212143 |
SUPPL-2 |
FOSAPREPITANT DIMEGLUMINE |
CHIA TAI TIANQING |
Labeling |
Approval |
| 09/16/2024 |
LEVOTHYROXINE SODIUM
ANDA #212399 |
SUPPL-6 |
LEVOTHYROXINE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 09/16/2024 |
LEVOTHYROXINE SODIUM
ANDA #212399 |
SUPPL-8 |
LEVOTHYROXINE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 09/16/2024 |
SACUBITRIL AND VALSARTAN
ANDA #213764 |
ORIG-1 |
SACUBITRIL; VALSARTAN |
ALKEM LABS LTD |
|
Approval |
| 09/16/2024 |
SIROLIMUS
ANDA #215080 |
ORIG-1 |
SIROLIMUS |
HETERO LABS LTD V |
|
Approval |
| 09/16/2024 |
LANREOTIDE ACETATE
NDA #215395 |
SUPPL-7 |
LANREOTIDE ACETATE |
INVAGEN PHARMS |
Efficacy |
Approval |
| 09/16/2024 |
CLOBAZAM
ANDA #216008 |
SUPPL-2 |
CLOBAZAM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 09/16/2024 |
IYUZEH
NDA #216472 |
SUPPL-2 |
LATANOPROST |
THEA PHARMA |
Labeling |
Approval |
| 09/16/2024 |
KETOCONAZOLE
ANDA #218498 |
ORIG-1 |
KETOCONAZOLE |
NOVITIUM PHARMA |
|
Approval |
| 09/17/2024 |
TRACLEER
NDA #021290 |
SUPPL-45 |
BOSENTAN |
ACTELION |
REMS |
Approval |
| 09/17/2024 |
LACTULOSE
ANDA #075911 |
SUPPL-12 |
LACTULOSE |
XTTRIUM LABS INC |
Manufacturing (CMC) |
Approval |
| 09/17/2024 |
KEYTRUDA
BLA #125514 |
SUPPL-161 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 09/17/2024 |
DONEPEZIL HYDROCHLORIDE
ANDA #200292 |
SUPPL-9 |
DONEPEZIL HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 09/17/2024 |
DONEPEZIL HYDROCHLORIDE
ANDA #200292 |
SUPPL-11 |
DONEPEZIL HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 09/17/2024 |
BOSENTAN
ANDA #205699 |
SUPPL-4 |
BOSENTAN |
ENDO OPERATIONS |
REMS |
Approval |
| 09/17/2024 |
BOSENTAN
ANDA #206987 |
SUPPL-5 |
BOSENTAN |
NATCO PHARMA LTD |
REMS |
Approval |
| 09/17/2024 |
BOSENTAN
ANDA #207110 |
SUPPL-8 |
BOSENTAN |
WATSON LABS INC |
REMS |
Approval |
| 09/17/2024 |
BOSENTAN
ANDA #207760 |
SUPPL-10 |
BOSENTAN |
ZYDUS PHARMS |
REMS |
Approval |
| 09/17/2024 |
KISQALI
NDA #209092 |
SUPPL-18 |
RIBOCICLIB SUCCINATE |
NOVARTIS |
Efficacy |
Approval |
| 09/17/2024 |
TRACLEER
NDA #209279 |
SUPPL-11 |
BOSENTAN |
ACTELION |
REMS |
Approval |
| 09/17/2024 |
BOSENTAN
ANDA #209324 |
SUPPL-10 |
BOSENTAN |
SUN PHARM |
REMS |
Approval |
| 09/17/2024 |
BOSENTAN
ANDA #209742 |
SUPPL-9 |
BOSENTAN |
AMNEAL PHARMS CO |
REMS |
Approval |
| 09/17/2024 |
KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935 |
SUPPL-27 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Efficacy |
Approval |
| 09/17/2024 |
EVRYSDI
NDA #213535 |
SUPPL-13 |
RISDIPLAM |
GENENTECH INC |
Efficacy |
Approval |
| 09/17/2024 |
METYROSINE
ANDA #215541 |
ORIG-1 |
METYROSINE |
LEADING |
|
Approval |
| 09/17/2024 |
PRAZOSIN HYDROCHLORIDE
ANDA #216727 |
ORIG-1 |
PRAZOSIN HYDROCHLORIDE |
MSN |
|
Approval |
| 09/17/2024 |
ERTUGLIFLOZIN
ANDA #217071 |
ORIG-1 |
ERTUGLIFLOZIN |
HETERO LABS LTD V |
|
Approval |
| 09/17/2024 |
BUMETANIDE
ANDA #217153 |
ORIG-1 |
BUMETANIDE |
LUPIN LTD |
|
Approval |
| 09/17/2024 |
DEXAMETHASONE
ANDA #218372 |
ORIG-1 |
DEXAMETHASONE |
COREPHARMA |
|
Approval |
| 09/17/2024 |
FASENRA
BLA #761070 |
SUPPL-21 |
BENRALIZUMAB |
ASTRAZENECA AB |
|
Approval |
| 09/18/2024 |
AMOXICILLIN
ANDA #065256 |
SUPPL-27 |
AMOXICILLIN |
AUROBINDO |
Manufacturing (CMC) |
Approval |
| 09/18/2024 |
ATENOLOL
ANDA #073457 |
SUPPL-47 |
ATENOLOL |
MYLAN |
Labeling |
Approval |
| 09/18/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077033 |
SUPPL-11 |
CITALOPRAM HYDROBROMIDE |
HERITAGE PHARMA |
Labeling |
Approval |
| 09/18/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077033 |
SUPPL-12 |
CITALOPRAM HYDROBROMIDE |
HERITAGE PHARMA |
Labeling |
Approval |
| 09/18/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077141 |
SUPPL-3 |
CITALOPRAM HYDROBROMIDE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/18/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077534 |
SUPPL-25 |
CITALOPRAM HYDROBROMIDE |
INVAGEN PHARMS |
Labeling |
Approval |
| 09/18/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #078216 |
SUPPL-39 |
CITALOPRAM HYDROBROMIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 09/18/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #078216 |
SUPPL-40 |
CITALOPRAM HYDROBROMIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 09/18/2024 |
RHOPRESSA
NDA #208254 |
SUPPL-14 |
NETARSUDIL MESYLATE |
ALCON LABS INC |
Labeling |
Approval |
| 09/18/2024 |
BUMETANIDE
ANDA #212931 |
ORIG-1 |
BUMETANIDE |
APPCO |
|
Approval |
| 09/19/2024 |
PYLERA
NDA #050786 |
SUPPL-27 |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
LABS JUVISE |
Labeling |
Approval |
| 09/19/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077038 |
SUPPL-16 |
CITALOPRAM HYDROBROMIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 09/19/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077038 |
SUPPL-17 |
CITALOPRAM HYDROBROMIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 09/19/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077038 |
SUPPL-18 |
CITALOPRAM HYDROBROMIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 09/19/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077038 |
SUPPL-19 |
CITALOPRAM HYDROBROMIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 09/19/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077042 |
SUPPL-38 |
CITALOPRAM HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 09/19/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077042 |
SUPPL-43 |
CITALOPRAM HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 09/19/2024 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #079124 |
SUPPL-10 |
LAMIVUDINE; ZIDOVUDINE |
HETERO LABS LTD III |
Labeling |
Approval |
| 09/19/2024 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #079124 |
SUPPL-14 |
LAMIVUDINE; ZIDOVUDINE |
HETERO LABS LTD III |
Labeling |
Approval |
| 09/19/2024 |
KINERET
BLA #103950 |
SUPPL-5198 |
ANAKINRA |
BIOVITRUM AB |
|
Approval |
| 09/19/2024 |
SOLIRIS
BLA #125166 |
SUPPL-447 |
ECULIZUMAB |
ALEXION PHARM |
|
Approval |
| 09/19/2024 |
ACTEMRA
BLA #125276 |
SUPPL-148 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 09/19/2024 |
ACTEMRA
BLA #125472 |
SUPPL-60 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 09/19/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #201448 |
SUPPL-5 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 09/19/2024 |
LANSOPRAZOLE
ANDA #202319 |
SUPPL-29 |
LANSOPRAZOLE |
PERRIGO R AND D |
Labeling |
Approval |
| 09/19/2024 |
LANSOPRAZOLE
ANDA #202319 |
SUPPL-33 |
LANSOPRAZOLE |
PERRIGO R AND D |
Labeling |
Approval |
| 09/19/2024 |
LANSOPRAZOLE
ANDA #202319 |
SUPPL-34 |
LANSOPRAZOLE |
PERRIGO R AND D |
Labeling |
Approval |
| 09/19/2024 |
GATTEX KIT
NDA #203441 |
SUPPL-22 |
TEDUGLUTIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 09/19/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #203864 |
SUPPL-10 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/19/2024 |
DAPAGLIFLOZIN; SAXAGLIPTIN
ANDA #211537 |
ORIG-1 |
DAPAGLIFLOZIN;SAXAGLIPTIN |
TORRENT PHARMS LTD |
|
Tentative Approval |
| 09/19/2024 |
NALBUPHINE HYDROCHLORIDE
ANDA #216049 |
ORIG-1 |
NALBUPHINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
| 09/19/2024 |
NALBUPHINE HYDROCHLORIDE
ANDA #216050 |
ORIG-1 |
NALBUPHINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
| 09/19/2024 |
ENALAPRIL MALEATE
ANDA #218531 |
ORIG-1 |
ENALAPRIL MALEATE |
UNIQUE PHARM |
|
Approval |
| 09/19/2024 |
ULTOMIRIS
BLA #761108 |
SUPPL-37 |
RAVULIZUMAB-CWVZ |
ALEXION PHARM |
|
Approval |
| 09/19/2024 |
RYBREVANT
BLA #761210 |
SUPPL-4 |
AMIVANTAMAB-VMJW |
JANSSEN BIOTECH |
|
Approval |
| 09/20/2024 |
DIAMOX
NDA #008943 |
SUPPL-53 |
ACETAZOLAMIDE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 09/20/2024 |
DIAMOX
NDA #009388 |
SUPPL-39 |
ACETAZOLAMIDE SODIUM |
TEVA WOMENS |
Labeling |
Approval |
| 09/20/2024 |
DIAMOX
NDA #012945 |
SUPPL-48 |
ACETAZOLAMIDE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 09/20/2024 |
CIPRO
NDA #019537 |
SUPPL-95 |
CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 09/20/2024 |
CIPRO
NDA #019847 |
SUPPL-64 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
| 09/20/2024 |
CIPRO
NDA #020780 |
SUPPL-50 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
| 09/20/2024 |
LEVOFLOXACIN
ANDA #077652 |
SUPPL-20 |
LEVOFLOXACIN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 09/20/2024 |
TACROLIMUS
ANDA #090596 |
SUPPL-28 |
TACROLIMUS |
MYLAN |
Manufacturing (CMC) |
Approval |
| 09/20/2024 |
LEVOFLOXACIN
ANDA #090722 |
SUPPL-16 |
LEVOFLOXACIN |
TORRENT PHARMS |
Labeling |
Approval |
| 09/20/2024 |
LEVOFLOXACIN
ANDA #091678 |
SUPPL-12 |
LEVOFLOXACIN |
NOVITIUM PHARMA |
Labeling |
Approval |
| 09/20/2024 |
ACTEMRA
BLA #125276 |
SUPPL-144 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 09/20/2024 |
ACTEMRA
BLA #125472 |
SUPPL-56 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 09/20/2024 |
LEVOFLOXACIN
ANDA #200250 |
SUPPL-7 |
LEVOFLOXACIN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 09/20/2024 |
FEXINIDAZOLE
NDA #214429 |
SUPPL-3 |
FEXINIDAZOLE |
SANOFI |
Labeling |
Approval |
| 09/20/2024 |
FEXINIDAZOLE
NDA #214429 |
SUPPL-4 |
FEXINIDAZOLE |
SANOFI |
Labeling |
Approval |
| 09/20/2024 |
MIPLYFFA
NDA #214927 |
ORIG-1 |
ARIMOCLOMOL |
ZEVRA DENMARK AS |
Type 1 - New Molecular Entity |
Approval |
| 09/20/2024 |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #216164 |
SUPPL-1 |
LEVOFLOXACIN |
KNACK |
Labeling |
Approval |
| 09/20/2024 |
SARCLISA
BLA #761113 |
SUPPL-14 |
ISATUXIMAB-IRFC |
SANOFI AVENTIS US |
|
Approval |
| 09/20/2024 |
BIMZELX
BLA #761151 |
SUPPL-5 |
BIMEKIZUMAB-BKZX |
UCB INC |
|
Approval |
| 09/20/2024 |
BIMZELX
BLA #761151 |
SUPPL-6 |
BIMEKIZUMAB-BKZX |
UCB INC |
|
Approval |
| 09/20/2024 |
BIMZELX
BLA #761151 |
SUPPL-7 |
BIMEKIZUMAB-BKZX |
UCB INC |
|
Approval |
