| 04/01/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #078458 |
SUPPL-20 |
METHYLPHENIDATE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/01/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #200886 |
SUPPL-6 |
METHYLPHENIDATE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 04/01/2024 |
IBUTILIDE FUMARATE
ANDA #204146 |
ORIG-1 |
IBUTILIDE FUMARATE |
AVET LIFESCIENCES |
|
Approval |
| 04/01/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #204659 |
SUPPL-1 |
METHYLPHENIDATE HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/01/2024 |
DEXTROAMPHETAMINE SULFATE
ANDA #205077 |
SUPPL-1 |
DEXTROAMPHETAMINE SULFATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/01/2024 |
DEXTROAMPHETAMINE SULFATE
ANDA #205077 |
SUPPL-2 |
DEXTROAMPHETAMINE SULFATE |
STRIDES PHARMA |
Labeling |
Approval |
| 04/01/2024 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #206734 |
SUPPL-5 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
| 04/01/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #207884 |
SUPPL-5 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 04/01/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #208737 |
SUPPL-2 |
METHYLPHENIDATE HYDROCHLORIDE |
CEDIPROF INC |
Labeling |
Approval |
| 04/01/2024 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #211715 |
SUPPL-2 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/01/2024 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #211715 |
SUPPL-5 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/01/2024 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #211715 |
SUPPL-11 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/01/2024 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #212037 |
SUPPL-7 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ELITE LABS INC |
Labeling |
Approval |
| 04/01/2024 |
TRANEXAMIC ACID
ANDA #212676 |
SUPPL-2 |
TRANEXAMIC ACID |
PROVEPHARM SAS |
Labeling |
Approval |
| 04/01/2024 |
MESALAMINE
ANDA #214585 |
SUPPL-4 |
MESALAMINE |
SUN PHARM |
Labeling |
Approval |
| 04/02/2024 |
DANTRIUM
NDA #018264 |
SUPPL-42 |
DANTROLENE SODIUM |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/02/2024 |
BIO-TROPIN
BLA #019774 |
SUPPL-63 |
SOMATROPIN |
FERRING |
|
Approval |
| 04/02/2024 |
ZOMACTON
BLA #019774 |
SUPPL-63 |
SOMATROPIN |
FERRING |
|
Approval |
| 04/02/2024 |
LIPITOR
NDA #020702 |
SUPPL-81 |
ATORVASTATIN CALCIUM |
UPJOHN |
Labeling |
Approval |
| 04/02/2024 |
FANAPT
NDA #022192 |
SUPPL-23 |
ILOPERIDONE |
VANDA PHARMS INC |
Efficacy |
Approval |
| 04/02/2024 |
CANDESARTAN CILEXETIL
ANDA #091390 |
SUPPL-1 |
CANDESARTAN CILEXETIL |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 04/02/2024 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202771 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/02/2024 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202771 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/02/2024 |
RIFAMPIN
ANDA #204101 |
SUPPL-11 |
RIFAMPIN |
AVET LIFESCIENCES |
Labeling |
Approval |
| 04/02/2024 |
RIFAMPIN
ANDA #204101 |
SUPPL-12 |
RIFAMPIN |
AVET LIFESCIENCES |
Labeling |
Approval |
| 04/02/2024 |
RYANODEX
NDA #205579 |
SUPPL-11 |
DANTROLENE SODIUM |
EAGLE PHARMS |
Labeling |
Approval |
| 04/02/2024 |
ATOVAQUONE
ANDA #210692 |
SUPPL-3 |
ATOVAQUONE |
HETERO LABS LTD III |
Labeling |
Approval |
| 04/02/2024 |
VORTIOXETINE HYDROBROMIDE
ANDA #211146 |
ORIG-1 |
VORTIOXETINE HYDROBROMIDE |
ZYDUS PHARMS |
|
Tentative Approval |
| 04/02/2024 |
FINTEPLA
NDA #212102 |
SUPPL-14 |
FENFLURAMINE HYDROCHLORIDE |
UCB INC |
REMS |
Approval |
| 04/02/2024 |
CLINDAMYCIN PHOSPHATE
ANDA #212466 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
ALEMBIC |
|
Approval |
| 04/02/2024 |
NALOXONE HYDROCHLORIDE
ANDA #213573 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 04/02/2024 |
ARFORMOTEROL TARTRATE
ANDA #214901 |
ORIG-1 |
ARFORMOTEROL TARTRATE |
PHARMAMAX |
|
Approval |
| 04/02/2024 |
FUROSEMIDE
ANDA #215856 |
ORIG-1 |
FUROSEMIDE |
SABA ILAC SANAYIVE |
|
Approval |
| 04/02/2024 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #215995 |
SUPPL-4 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/02/2024 |
LACOSAMIDE
ANDA #218014 |
ORIG-1 |
LACOSAMIDE |
MEDLEY PHARMS |
|
Approval |
| 04/03/2024 |
ALLOPURINOL
NDA #018832 |
SUPPL-56 |
ALLOPURINOL |
WATSON LABS |
Labeling |
Approval |
| 04/03/2024 |
ALLOPURINOL
NDA #018832 |
SUPPL-58 |
ALLOPURINOL |
WATSON LABS |
Labeling |
Approval |
| 04/03/2024 |
ALLOPURINOL
NDA #018832 |
SUPPL-61 |
ALLOPURINOL |
WATSON LABS |
Labeling |
Approval |
| 04/03/2024 |
ALLOPURINOL
NDA #018877 |
SUPPL-63 |
ALLOPURINOL |
WATSON LABS |
Labeling |
Approval |
| 04/03/2024 |
ALLOPURINOL
NDA #018877 |
SUPPL-65 |
ALLOPURINOL |
WATSON LABS |
Labeling |
Approval |
| 04/03/2024 |
ALLOPURINOL
NDA #018877 |
SUPPL-68 |
ALLOPURINOL |
WATSON LABS |
Labeling |
Approval |
| 04/03/2024 |
APTIVUS
NDA #021814 |
SUPPL-30 |
TIPRANAVIR |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 04/03/2024 |
PERCOCET
ANDA #040330 |
SUPPL-61 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/03/2024 |
BUPROPION HYDROCHLORIDE
ANDA #079094 |
SUPPL-30 |
BUPROPION HYDROCHLORIDE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 04/03/2024 |
BUPROPION HYDROCHLORIDE
ANDA #079094 |
SUPPL-33 |
BUPROPION HYDROCHLORIDE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 04/03/2024 |
BUPROPION HYDROCHLORIDE
ANDA #079094 |
SUPPL-35 |
BUPROPION HYDROCHLORIDE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 04/03/2024 |
PERCOCET
ANDA #085106 |
SUPPL-32 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/03/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #090734 |
SUPPL-30 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/03/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #201278 |
SUPPL-20 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
RHODES PHARMS |
Labeling |
Approval |
| 04/03/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #201972 |
SUPPL-18 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 04/03/2024 |
MYTESI
NDA #202292 |
SUPPL-9 |
CROFELEMER |
NAPO PHARMS INC |
Labeling |
Approval |
| 04/03/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #203557 |
SUPPL-27 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/03/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #203557 |
SUPPL-28 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/03/2024 |
LENVIMA
NDA #206947 |
SUPPL-30 |
LENVATINIB MESYLATE |
EISAI INC |
Efficacy |
Approval |
| 04/03/2024 |
CARBOPROST TROMETHAMINE
ANDA #218013 |
ORIG-1 |
CARBOPROST TROMETHAMINE |
MICRO LABS |
|
Approval |
| 04/03/2024 |
ZEVTERA
NDA #218275 |
ORIG-1 |
CEFTOBIPROLE MEDOCARIL SODIUM |
BASILEA PHARM ALLSCH |
Type 1 - New Molecular Entity |
Approval |
| 04/03/2024 |
VORICONAZOLE
ANDA #218533 |
ORIG-1 |
VORICONAZOLE |
ASPIRO |
|
Approval |
| 04/03/2024 |
ILUMYA
BLA #761067 |
SUPPL-18 |
TILDRAKIZUMAB-ASMN |
SUN PHARMA GLOBAL |
|
Approval |
| 04/04/2024 |
CAMPTOSAR
NDA #020571 |
SUPPL-56 |
IRINOTECAN HYDROCHLORIDE |
PFIZER INC |
Manufacturing (CMC) |
Approval |
| 04/04/2024 |
DOXYLAMINE SUCCINATE
ANDA #040167 |
SUPPL-52 |
DOXYLAMINE SUCCINATE |
PERRIGO |
Manufacturing (CMC) |
Approval |
| 04/04/2024 |
AMOXICILLIN
ANDA #065271 |
SUPPL-15 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN
ANDA #065271 |
SUPPL-16 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN
ANDA #065271 |
SUPPL-19 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN
ANDA #065271 |
SUPPL-23 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/04/2024 |
BUTORPHANOL TARTRATE PRESERVATIVE FREE
ANDA #074626 |
SUPPL-38 |
BUTORPHANOL TARTRATE |
HOSPIRA |
Labeling |
Approval |
| 04/04/2024 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-11 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/04/2024 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-12 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/04/2024 |
PACLITAXEL
ANDA #077574 |
SUPPL-15 |
PACLITAXEL |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/04/2024 |
PACLITAXEL
ANDA #077574 |
SUPPL-17 |
PACLITAXEL |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/04/2024 |
PACLITAXEL
ANDA #077574 |
SUPPL-20 |
PACLITAXEL |
FRESENIUS KABI USA |
Labeling |
Approval |
| 04/04/2024 |
ROPINIROLE HYDROCHLORIDE
ANDA #077852 |
SUPPL-12 |
ROPINIROLE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/04/2024 |
ROPINIROLE HYDROCHLORIDE
ANDA #077852 |
SUPPL-13 |
ROPINIROLE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/04/2024 |
HYDROCHLOROTHIAZIDE
ANDA #077885 |
SUPPL-4 |
HYDROCHLOROTHIAZIDE |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 04/04/2024 |
HYDROCHLOROTHIAZIDE
ANDA #078164 |
SUPPL-11 |
HYDROCHLOROTHIAZIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #204755 |
SUPPL-5 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #204755 |
SUPPL-6 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #204755 |
SUPPL-9 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205707 |
SUPPL-5 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205707 |
SUPPL-6 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/04/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205707 |
SUPPL-9 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/04/2024 |
PITAVASTATIN CALCIUM
ANDA #205932 |
SUPPL-1 |
PITAVASTATIN CALCIUM |
ORIENT PHARMA CO LTD |
Labeling |
Approval |
| 04/04/2024 |
IMIPENEM AND CILASTATIN
ANDA #207594 |
SUPPL-2 |
CILASTATIN SODIUM; IMIPENEM |
HQ SPCLT PHARMA |
Labeling |
Approval |
| 04/04/2024 |
CABAZITAXEL
ANDA #207736 |
SUPPL-2 |
CABAZITAXEL |
APOTEX |
Labeling |
Approval |
| 04/04/2024 |
XIIDRA
NDA #208073 |
SUPPL-12 |
LIFITEGRAST |
BAUSCH AND LOMB INC |
Manufacturing (CMC) |
Approval |
| 04/04/2024 |
TERIFLUNOMIDE
ANDA #209697 |
ORIG-1 |
TERIFLUNOMIDE |
TORRENT |
|
Approval |
| 04/04/2024 |
SIROLIMUS
ANDA #211406 |
SUPPL-1 |
SIROLIMUS |
APOTEX |
Labeling |
Approval |
| 04/04/2024 |
SIROLIMUS
ANDA #211406 |
SUPPL-4 |
SIROLIMUS |
APOTEX |
Labeling |
Approval |
| 04/04/2024 |
MESALAMINE
ANDA #214242 |
SUPPL-3 |
MESALAMINE |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/04/2024 |
XROMI
NDA #216593 |
ORIG-1 |
HYDROXYUREA |
NOVA LABS LTD |
Type 3 - New Dosage Form |
Approval |
| 04/04/2024 |
XROMI
NDA #216593 |
ORIG-2 |
HYDROXYUREA |
NOVA LABS LTD |
Type 3 - New Dosage Form |
Tentative Approval |
| 04/04/2024 |
OGSIVEO
NDA #217677 |
SUPPL-1 |
NIROGACESTAT HYDROBROMIDE |
SPRINGWORKS |
Manufacturing (CMC) |
Approval |
| 04/04/2024 |
COSENTYX
BLA #761349 |
SUPPL-1 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
| 04/05/2024 |
AMOXICILLIN
ANDA #065291 |
SUPPL-32 |
AMOXICILLIN |
HIKMA PHARMS |
Labeling |
Approval |
| 04/05/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065523 |
SUPPL-26 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 04/05/2024 |
CLOZAPINE
ANDA #076809 |
SUPPL-42 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 04/05/2024 |
CLOZAPINE
ANDA #076809 |
SUPPL-46 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 04/05/2024 |
CLOZAPINE
ANDA #076809 |
SUPPL-51 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 04/05/2024 |
LEVETIRACETAM
ANDA #078869 |
SUPPL-3 |
LEVETIRACETAM |
VIWIT PHARM |
Labeling |
Approval |
| 04/05/2024 |
LEVETIRACETAM
ANDA #078869 |
SUPPL-4 |
LEVETIRACETAM |
VIWIT PHARM |
Labeling |
Approval |
| 04/05/2024 |
LEVETIRACETAM
ANDA #078869 |
SUPPL-5 |
LEVETIRACETAM |
VIWIT PHARM |
Labeling |
Approval |
| 04/05/2024 |
LEVETIRACETAM
ANDA #078869 |
SUPPL-6 |
LEVETIRACETAM |
VIWIT PHARM |
Labeling |
Approval |
| 04/05/2024 |
LARIN 1.5/30
ANDA #202996 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 04/05/2024 |
LARIN 1.5/30
ANDA #202996 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 04/05/2024 |
LARIN 1.5/30
ANDA #202996 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 04/05/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #203719 |
SUPPL-9 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
FRESENIUS KABI |
Labeling |
Approval |
| 04/05/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #203719 |
SUPPL-10 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
FRESENIUS KABI |
Labeling |
Approval |
| 04/05/2024 |
ETHINYL ESTRADIOL; ETONOGESTREL
ANDA #204305 |
SUPPL-7 |
ETHINYL ESTRADIOL; ETONOGESTREL |
TEVA PHARMS USA INC |
Labeling |
Approval |
| 04/05/2024 |
LINEZOLID
ANDA #205517 |
SUPPL-7 |
LINEZOLID |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/05/2024 |
LINEZOLID
ANDA #205517 |
SUPPL-9 |
LINEZOLID |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/05/2024 |
LINEZOLID
ANDA #205517 |
SUPPL-13 |
LINEZOLID |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/05/2024 |
LACOSAMIDE
ANDA #206355 |
SUPPL-1 |
LACOSAMIDE |
APOTEX |
Labeling |
Approval |
| 04/05/2024 |
LACOSAMIDE
ANDA #206355 |
SUPPL-2 |
LACOSAMIDE |
APOTEX |
Labeling |
Approval |
| 04/05/2024 |
LACOSAMIDE
ANDA #206355 |
SUPPL-3 |
LACOSAMIDE |
APOTEX |
Labeling |
Approval |
| 04/05/2024 |
MITOMYCIN
ANDA #211269 |
ORIG-1 |
MITOMYCIN |
FRESENIUS KABI USA |
|
Approval |
| 04/05/2024 |
DOVATO
NDA #211994 |
SUPPL-18 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 04/05/2024 |
DOVATO
NDA #211994 |
SUPPL-19 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 04/05/2024 |
FLUOXETINE HYDROCHLORIDE
ANDA #212684 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
| 04/05/2024 |
XCOPRI
NDA #212839 |
SUPPL-9 |
CENOBAMATE |
SK LIFE |
Labeling |
Approval |
| 04/05/2024 |
XCOPRI
NDA #212839 |
SUPPL-10 |
CENOBAMATE |
SK LIFE |
Labeling |
Approval |
| 04/05/2024 |
DAPTOMYCIN
ANDA #213425 |
SUPPL-3 |
DAPTOMYCIN |
BE PHARMS |
Labeling |
Approval |
| 04/05/2024 |
VALBENAZINE TOSYLATE
ANDA #216064 |
ORIG-1 |
VALBENAZINE TOSYLATE |
LUPIN LTD |
|
Approval |
| 04/05/2024 |
VALBENAZINE TOSYLATE
ANDA #216064 |
ORIG-2 |
VALBENAZINE TOSYLATE |
LUPIN LTD |
|
Tentative Approval |
| 04/05/2024 |
PANTOPRAZOLE SODIUM
ANDA #216247 |
SUPPL-1 |
PANTOPRAZOLE SODIUM |
DEXCEL |
Labeling |
Approval |
| 04/05/2024 |
PANTOPRAZOLE SODIUM
ANDA #216247 |
SUPPL-2 |
PANTOPRAZOLE SODIUM |
DEXCEL |
Labeling |
Approval |
| 04/05/2024 |
LACOSAMIDE
ANDA #216806 |
ORIG-1 |
LACOSAMIDE |
HIKMA |
|
Approval |
| 04/05/2024 |
TAFLUPROST
ANDA #218002 |
ORIG-1 |
TAFLUPROST |
INGENUS PHARMS LLC |
|
Approval |
| 04/05/2024 |
ERIBULIN MESYLATE
ANDA #218047 |
ORIG-1 |
ERIBULIN MESYLATE |
GLAND PHARMA LTD |
|
Approval |
| 04/05/2024 |
FASENRA
BLA #761070 |
SUPPL-20 |
BENRALIZUMAB |
ASTRAZENECA AB |
|
Approval |
| 04/05/2024 |
HYRIMOZ
BLA #761071 |
SUPPL-19 |
ADALIMUMAB-ADAZ |
SANDOZ INC |
|
Approval |
| 04/05/2024 |
LIBTAYO
BLA #761097 |
SUPPL-23 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 04/05/2024 |
ENHERTU
BLA #761139 |
SUPPL-28 |
FAM-TRASTUZUMAB DERUXTECAN-NXKI |
DAIICHI SANKYO |
|
Approval |
| 04/08/2024 |
ENVARSUS XR
NDA #206406 |
SUPPL-9 |
TACROLIMUS |
VELOXIS PHARMS INC |
Labeling |
Approval |
| 04/08/2024 |
ATROPINE SULFATE
ANDA #212461 |
SUPPL-1 |
ATROPINE SULFATE |
INTL MEDICATION SYS |
Labeling |
Approval |
| 04/08/2024 |
IBUPROFEN
ANDA #213506 |
ORIG-1 |
IBUPROFEN |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/08/2024 |
DOXYCYCLINE
ANDA #216631 |
ORIG-1 |
DOXYCYCLINE |
LUPIN |
|
Approval |
| 04/08/2024 |
DEXTROSE 5%
ANDA #217263 |
ORIG-1 |
DEXTROSE |
AM REGENT |
|
Approval |
| 04/08/2024 |
GABAPENTIN
ANDA #217965 |
ORIG-1 |
GABAPENTIN |
LAURUS |
|
Approval |
| 04/08/2024 |
DOXYCYCLINE
ANDA #218034 |
ORIG-1 |
DOXYCYCLINE |
DR REDDYS |
|
Approval |
| 04/09/2024 |
AMOXICILLIN
ANDA #065334 |
SUPPL-11 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/09/2024 |
AMOXICILLIN
ANDA #065334 |
SUPPL-12 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/09/2024 |
AMOXICILLIN
ANDA #065334 |
SUPPL-14 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/09/2024 |
AMOXICILLIN
ANDA #065334 |
SUPPL-20 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/09/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065458 |
SUPPL-15 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
STERISCIENCE |
Labeling |
Approval |
| 04/09/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #090733 |
SUPPL-24 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/09/2024 |
CEFPROZIL
ANDA #090857 |
ORIG-1 |
CEFPROZIL |
ALKEM LABS LTD |
|
Approval |
| 04/09/2024 |
PROLIA
BLA #125320 |
SUPPL-218 |
DENOSUMAB |
AMGEN |
|
Approval |
| 04/09/2024 |
XGEVA
BLA #125320 |
SUPPL-218 |
DENOSUMAB |
AMGEN |
|
Approval |
| 04/09/2024 |
OLOPATADINE HYDROCHLORIDE
ANDA #206306 |
SUPPL-11 |
OLOPATADINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 04/09/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #206996 |
SUPPL-8 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WOCKHARDT BIO AG |
Labeling |
Approval |
| 04/09/2024 |
TOFACITINIB
ANDA #209923 |
ORIG-1 |
TOFACITINIB |
PRINSTON PHARMA INC |
|
Tentative Approval |
| 04/09/2024 |
HYDROXYUREA
ANDA #213438 |
SUPPL-1 |
HYDROXYUREA |
LEADING |
Labeling |
Approval |
| 04/09/2024 |
HYDROXYUREA
ANDA #213438 |
SUPPL-3 |
HYDROXYUREA |
LEADING |
Labeling |
Approval |
| 04/09/2024 |
EVEROLIMUS
ANDA #214182 |
SUPPL-10 |
EVEROLIMUS |
BIOCON PHARMA |
Labeling |
Approval |
| 04/09/2024 |
VENLAFAXINE HYDROCHLORIDE
ANDA #214609 |
SUPPL-2 |
VENLAFAXINE HYDROCHLORIDE |
APPCO |
Labeling |
Approval |
| 04/09/2024 |
IOPAMIDOL
ANDA #217134 |
SUPPL-1 |
IOPAMIDOL |
HAINAN POLY |
Manufacturing (CMC) |
Approval |
| 04/09/2024 |
RASAGILINE MESYLATE
ANDA #218163 |
ORIG-1 |
RASAGILINE MESYLATE |
SKG PHARMA |
|
Approval |
| 04/10/2024 |
BUPROPION HYDROCHLORIDE
ANDA #202775 |
SUPPL-6 |
BUPROPION HYDROCHLORIDE |
JUBILANT GENERICS |
Labeling |
Approval |
| 04/10/2024 |
BUPROPION HYDROCHLORIDE
ANDA #202775 |
SUPPL-14 |
BUPROPION HYDROCHLORIDE |
JUBILANT GENERICS |
Labeling |
Approval |
| 04/10/2024 |
SEVELAMER CARBONATE
ANDA #206100 |
SUPPL-3 |
SEVELAMER CARBONATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 04/10/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #207146 |
SUPPL-8 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WOCKHARDT BIO AG |
Labeling |
Approval |
| 04/10/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #208674 |
SUPPL-3 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
| 04/10/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #208674 |
SUPPL-4 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
| 04/10/2024 |
SPINRAZA
NDA #209531 |
SUPPL-13 |
NUSINERSEN SODIUM |
BIOGEN IDEC |
Labeling |
Approval |
| 04/10/2024 |
SPINRAZA
NDA #209531 |
SUPPL-14 |
NUSINERSEN SODIUM |
BIOGEN IDEC |
Labeling |
Approval |
| 04/10/2024 |
RETEVMO
NDA #213246 |
SUPPL-10 |
SELPERCATINIB |
LOXO ONCOL ELI LILLY |
Labeling |
Approval |
| 04/10/2024 |
REZUROCK
NDA #214783 |
SUPPL-5 |
BELUMOSUDIL MESYLATE |
KADMON PHARMS LLC |
Labeling |
Approval |
| 04/10/2024 |
TOPIRAMATE
ANDA #215918 |
ORIG-1 |
TOPIRAMATE |
TORRENT PHARMS LTD |
|
Tentative Approval |
| 04/10/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #217229 |
SUPPL-1 |
METHYLPHENIDATE HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
| 04/10/2024 |
RETEVMO
NDA #218160 |
ORIG-1 |
SELPERCATINIB |
LOXO ONCOL ELI LILLY |
Type 3 - New Dosage Form |
Approval |
| 04/10/2024 |
NICARDIPINE HYDROCHLORIDE
ANDA #218202 |
ORIG-1 |
NICARDIPINE HYDROCHLORIDE |
SKG PHARMA |
|
Approval |
| 04/10/2024 |
BETAMETHASONE DIPROPIONATE
ANDA #218289 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/11/2024 |
ZOSYN IN PLASTIC CONTAINER
NDA #050750 |
SUPPL-50 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
| 04/11/2024 |
AMOXICILLIN
ANDA #065256 |
SUPPL-13 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/11/2024 |
AMOXICILLIN
ANDA #065256 |
SUPPL-14 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/11/2024 |
AMOXICILLIN
ANDA #065256 |
SUPPL-17 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/11/2024 |
AMOXICILLIN
ANDA #065256 |
SUPPL-21 |
AMOXICILLIN |
AUROBINDO |
Labeling |
Approval |
| 04/11/2024 |
DIAZEPAM
ANDA #070325 |
SUPPL-24 |
DIAZEPAM |
MYLAN |
Labeling |
Approval |
| 04/11/2024 |
DIAZEPAM
ANDA #070325 |
SUPPL-25 |
DIAZEPAM |
MYLAN |
Labeling |
Approval |
| 04/11/2024 |
DIAZEPAM
ANDA #070325 |
SUPPL-27 |
DIAZEPAM |
MYLAN |
Labeling |
Approval |
| 04/11/2024 |
DIAZEPAM
ANDA #070325 |
SUPPL-30 |
DIAZEPAM |
MYLAN |
Labeling |
Approval |
| 04/11/2024 |
INDOMETHACIN
ANDA #070673 |
SUPPL-23 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
| 04/11/2024 |
INDOMETHACIN
ANDA #070674 |
SUPPL-23 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
| 04/11/2024 |
LISINOPRIL
ANDA #076063 |
SUPPL-67 |
LISINOPRIL |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 04/11/2024 |
LISINOPRIL
ANDA #076071 |
SUPPL-34 |
LISINOPRIL |
STRIDES PHARMA |
Labeling |
Approval |
| 04/11/2024 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078020 |
SUPPL-15 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
MYLAN PHARMS INC |
Labeling |
Approval |
| 04/11/2024 |
LAMOTRIGINE
ANDA #079099 |
SUPPL-15 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/11/2024 |
LAMOTRIGINE
ANDA #079099 |
SUPPL-16 |
LAMOTRIGINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090248 |
SUPPL-6 |
ALPRAZOLAM |
STRIDES PHARMA |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090248 |
SUPPL-7 |
ALPRAZOLAM |
STRIDES PHARMA |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090248 |
SUPPL-8 |
ALPRAZOLAM |
STRIDES PHARMA |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090871 |
SUPPL-8 |
ALPRAZOLAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090871 |
SUPPL-10 |
ALPRAZOLAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090871 |
SUPPL-11 |
ALPRAZOLAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/11/2024 |
ALPRAZOLAM
ANDA #090871 |
SUPPL-12 |
ALPRAZOLAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/11/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201091 |
SUPPL-2 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/11/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201091 |
SUPPL-4 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/11/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201091 |
SUPPL-10 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/11/2024 |
OPSUMIT
NDA #204410 |
SUPPL-27 |
MACITENTAN |
ACTELION |
REMS |
Approval |
| 04/11/2024 |
PLERIXAFOR
ANDA #205197 |
SUPPL-2 |
PLERIXAFOR |
TEVA PHARMS USA INC |
Labeling |
Approval |
| 04/11/2024 |
ADAPALENE AND BENZOYL PEROXIDE
ANDA #209148 |
SUPPL-7 |
ADAPALENE; BENZOYL PEROXIDE |
TARO |
Labeling |
Approval |
| 04/11/2024 |
MACITENTAN
ANDA #211195 |
SUPPL-1 |
MACITENTAN |
APOTEX |
REMS |
Approval |
| 04/11/2024 |
MACITENTAN
ANDA #211198 |
SUPPL-2 |
MACITENTAN |
AUROBINDO PHARMA LTD |
REMS |
Approval |
| 04/11/2024 |
MACITENTAN
ANDA #211224 |
SUPPL-2 |
MACITENTAN |
ZYDUS LIFESCIENCES |
REMS |
Approval |
| 04/11/2024 |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
ANDA #211404 |
ORIG-1 |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
PLD ACQUISITIONS LLC |
|
Approval |
| 04/11/2024 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #213473 |
SUPPL-2 |
METHYLPHENIDATE HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 04/11/2024 |
PLERIXAFOR
ANDA #215334 |
SUPPL-2 |
PLERIXAFOR |
AMNEAL |
Labeling |
Approval |
| 04/11/2024 |
CALCITONIN-SALMON
ANDA #215715 |
ORIG-1 |
CALCITONIN SALMON |
DR REDDYS |
|
Approval |
| 04/11/2024 |
DOCETAXEL
NDA #215813 |
SUPPL-1 |
DOCETAXEL |
AVYXA HOLDINGS |
Labeling |
Approval |
| 04/11/2024 |
DOCETAXEL
NDA #215813 |
SUPPL-2 |
DOCETAXEL |
AVYXA HOLDINGS |
Labeling |
Approval |
| 04/11/2024 |
DOCIVYX
NDA #215813 |
SUPPL-1 |
DOCETAXEL |
AVYXA HOLDINGS |
Labeling |
Approval |
| 04/11/2024 |
DOCIVYX
NDA #215813 |
SUPPL-2 |
DOCETAXEL |
AVYXA HOLDINGS |
Labeling |
Approval |
| 04/11/2024 |
VIVJOA
NDA #215888 |
SUPPL-2 |
OTESECONAZOLE |
MYCOVIA PHARMS |
Labeling |
Approval |
| 04/11/2024 |
HALOPERIDOL
ANDA #216918 |
ORIG-1 |
HALOPERIDOL |
MANKIND PHARMA |
|
Approval |
| 04/11/2024 |
EMPAGLIFLOZIN
ANDA #217600 |
ORIG-1 |
EMPAGLIFLOZIN |
PRINSTON PHARMA INC |
|
Tentative Approval |
| 04/11/2024 |
CABLIVI
BLA #761112 |
SUPPL-11 |
CAPLACIZUMAB-YHDP |
ABLYNX NV |
|
Approval |
| 04/12/2024 |
TRELSTAR
NDA #020715 |
SUPPL-49 |
TRIPTORELIN PAMOATE |
VERITY |
Labeling |
Approval |
| 04/12/2024 |
TRELSTAR
NDA #021288 |
SUPPL-44 |
TRIPTORELIN PAMOATE |
VERITY |
Labeling |
Approval |
| 04/12/2024 |
TRELSTAR
NDA #022437 |
SUPPL-24 |
TRIPTORELIN PAMOATE |
VERITY |
Labeling |
Approval |
| 04/12/2024 |
MEPERIDINE HYDROCHLORIDE
ANDA #040331 |
SUPPL-21 |
MEPERIDINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 04/12/2024 |
MEPERIDINE HYDROCHLORIDE
ANDA #040331 |
SUPPL-22 |
MEPERIDINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 04/12/2024 |
PHENYTOIN
ANDA #040342 |
SUPPL-23 |
PHENYTOIN |
VISTAPHARM |
Labeling |
Approval |
| 04/12/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065523 |
SUPPL-27 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 04/12/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065523 |
SUPPL-28 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 04/12/2024 |
RIFABUTIN
ANDA #090033 |
SUPPL-4 |
RIFABUTIN |
LUPIN LTD |
Labeling |
Approval |
| 04/12/2024 |
RIFABUTIN
ANDA #090033 |
SUPPL-5 |
RIFABUTIN |
LUPIN LTD |
Labeling |
Approval |
| 04/12/2024 |
RIFABUTIN
ANDA #090033 |
SUPPL-6 |
RIFABUTIN |
LUPIN LTD |
Labeling |
Approval |
| 04/12/2024 |
DOXYCYCLINE HYCLATE
ANDA #090134 |
SUPPL-23 |
DOXYCYCLINE HYCLATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 04/12/2024 |
DOXYCYCLINE HYCLATE
ANDA #090134 |
SUPPL-26 |
DOXYCYCLINE HYCLATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 04/12/2024 |
ARZERRA
BLA #125326 |
SUPPL-79 |
OFATUMUMAB |
NOVARTIS |
|
Approval |
| 04/12/2024 |
KESIMPTA
BLA #125326 |
SUPPL-79 |
OFATUMUMAB |
NOVARTIS |
|
Approval |
| 04/12/2024 |
RIZATRIPTAN BENZOATE
ANDA #203252 |
SUPPL-7 |
RIZATRIPTAN BENZOATE |
JUBILANT GENERICS |
Labeling |
Approval |
| 04/12/2024 |
AMOXICILLIN
ANDA #204030 |
SUPPL-10 |
AMOXICILLIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/12/2024 |
ENTRESTO
NDA #207620 |
SUPPL-25 |
SACUBITRIL; VALSARTAN |
NOVARTIS PHARMS CORP |
Efficacy |
Approval |
| 04/12/2024 |
MESALAMINE
ANDA #210509 |
SUPPL-8 |
MESALAMINE |
AMNEAL |
Labeling |
Approval |
| 04/12/2024 |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #211013 |
SUPPL-2 |
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE |
INVENTIA |
Labeling |
Approval |
| 04/12/2024 |
PIRFENIDONE
ANDA #212077 |
SUPPL-2 |
PIRFENIDONE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 04/12/2024 |
PIRFENIDONE
ANDA #212078 |
SUPPL-3 |
PIRFENIDONE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 04/12/2024 |
TOPIRAMATE
ANDA #215638 |
ORIG-1 |
TOPIRAMATE |
XIAMEN LP PHARM CO |
|
Tentative Approval |
| 04/12/2024 |
MESALAMINE
ANDA #216941 |
SUPPL-1 |
MESALAMINE |
ENCUBE |
Labeling |
Approval |
| 04/12/2024 |
OFLOXACIN
ANDA #217904 |
ORIG-1 |
OFLOXACIN |
CAPLIN |
|
Approval |
| 04/12/2024 |
ENTRESTO SPRINKLE
NDA #218591 |
ORIG-1 |
SACUBITRIL; VALSARTAN |
NOVARTIS |
Type 3 - New Dosage Form |
Approval |
| 04/12/2024 |
DUPIXENT
BLA #761055 |
SUPPL-59 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 04/15/2024 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040081 |
SUPPL-35 |
HYDROXYCHLOROQUINE SULFATE |
TEVA PHARMS |
Labeling |
Approval |
| 04/15/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065317 |
SUPPL-3 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
APOTEX INC |
Labeling |
Approval |
| 04/15/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065333 |
SUPPL-3 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
APOTEX INC |
Labeling |
Approval |
| 04/15/2024 |
BUPROPION HYDROCHLORIDE
ANDA #076834 |
SUPPL-15 |
BUPROPION HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 04/15/2024 |
METFORMIN HYDROCHLORIDE
ANDA #079118 |
SUPPL-16 |
METFORMIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Manufacturing (CMC) |
Approval |
| 04/15/2024 |
ESCITALOPRAM OXALATE
ANDA #202227 |
SUPPL-19 |
ESCITALOPRAM OXALATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/15/2024 |
URSODIOL
ANDA #202540 |
SUPPL-8 |
URSODIOL |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/15/2024 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE
ANDA #206958 |
SUPPL-1 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 04/15/2024 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE
ANDA #206958 |
SUPPL-2 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 04/15/2024 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE
ANDA #206958 |
SUPPL-3 |
CLINDAMYCIN PALMITATE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 04/15/2024 |
ASPIRIN AND DIPYRIDAMOLE
ANDA #206964 |
SUPPL-8 |
ASPIRIN; DIPYRIDAMOLE |
ANI PHARMS |
Labeling |
Approval |
| 04/15/2024 |
ASPIRIN AND DIPYRIDAMOLE
ANDA #206964 |
SUPPL-10 |
ASPIRIN; DIPYRIDAMOLE |
ANI PHARMS |
Labeling |
Approval |
| 04/15/2024 |
BUPROPION HYDROCHLORIDE
ANDA #207403 |
SUPPL-2 |
BUPROPION HYDROCHLORIDE |
MICRO LABS |
Labeling |
Approval |
| 04/15/2024 |
BUPROPION HYDROCHLORIDE
ANDA #207403 |
SUPPL-3 |
BUPROPION HYDROCHLORIDE |
MICRO LABS |
Labeling |
Approval |
| 04/15/2024 |
FINGOLIMOD HYDROCHLORIDE
ANDA #208000 |
SUPPL-1 |
FINGOLIMOD HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 04/15/2024 |
FINGOLIMOD HYDROCHLORIDE
ANDA #208000 |
SUPPL-2 |
FINGOLIMOD HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
| 04/15/2024 |
FINGOLIMOD HYDROCHLORIDE
ANDA #208005 |
SUPPL-4 |
FINGOLIMOD HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/15/2024 |
FINGOLIMOD HYDROCHLORIDE
ANDA #208005 |
SUPPL-5 |
FINGOLIMOD HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 04/15/2024 |
EZETIMIBE
ANDA #208332 |
SUPPL-6 |
EZETIMIBE |
APOTEX |
Labeling |
Approval |
| 04/15/2024 |
CAPECITABINE
ANDA #209365 |
SUPPL-5 |
CAPECITABINE |
MSN |
Labeling |
Approval |
| 04/15/2024 |
CAPECITABINE
ANDA #209365 |
SUPPL-7 |
CAPECITABINE |
MSN |
Labeling |
Approval |
| 04/15/2024 |
DOXYCYCLINE HYCLATE
ANDA #209560 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
NOSTRUM LABS INC |
|
Approval |
| 04/15/2024 |
FINGOLIMOD HYDROCHLORIDE
ANDA #210252 |
SUPPL-1 |
FINGOLIMOD HYDROCHLORIDE |
BIONPHARMA |
Labeling |
Approval |
| 04/15/2024 |
EXTENDED PHENYTOIN SODIUM
ANDA #211633 |
SUPPL-3 |
PHENYTOIN SODIUM |
LUPIN LTD |
Labeling |
Approval |
| 04/15/2024 |
EXTENDED PHENYTOIN SODIUM
ANDA #211633 |
SUPPL-5 |
PHENYTOIN SODIUM |
LUPIN LTD |
Labeling |
Approval |
| 04/15/2024 |
LAMOTRIGINE
ANDA #213271 |
SUPPL-2 |
LAMOTRIGINE |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 04/15/2024 |
DOXYCYCLINE HYCLATE
ANDA #214356 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
TORRENT |
|
Approval |
| 04/15/2024 |
PANTOPRAZOLE SODIUM
ANDA #214680 |
SUPPL-1 |
PANTOPRAZOLE SODIUM |
KNACK |
Labeling |
Approval |
| 04/15/2024 |
BENDAMUSTINE HYDROCHLORIDE
NDA #215033 |
SUPPL-3 |
BENDAMUSTINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 04/15/2024 |
RYLAZE
BLA #761179 |
SUPPL-7 |
ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN |
JAZZ PHARMS |
|
Approval |
| 04/16/2024 |
CITALOPRAM HYDROBROMIDE
ANDA #077534 |
SUPPL-24 |
CITALOPRAM HYDROBROMIDE |
INVAGEN PHARMS |
Labeling |
Approval |
| 04/16/2024 |
MEPERIDINE HYDROCHLORIDE
ANDA #088639 |
SUPPL-48 |
MEPERIDINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 04/16/2024 |
MEPERIDINE HYDROCHLORIDE
ANDA #088640 |
SUPPL-50 |
MEPERIDINE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 04/16/2024 |
CARVEDILOL PHOSPHATE
ANDA #090132 |
SUPPL-2 |
CARVEDILOL PHOSPHATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/16/2024 |
CARVEDILOL PHOSPHATE
ANDA #090132 |
SUPPL-5 |
CARVEDILOL PHOSPHATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/16/2024 |
BUPROPION HYDROCHLORIDE
ANDA #090941 |
SUPPL-13 |
BUPROPION HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 04/16/2024 |
BUPROPION HYDROCHLORIDE
ANDA #090941 |
SUPPL-15 |
BUPROPION HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 04/16/2024 |
PANTOPRAZOLE SODIUM
ANDA #202052 |
SUPPL-10 |
PANTOPRAZOLE SODIUM |
ORBION PHARMS |
Labeling |
Approval |
| 04/16/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205187 |
SUPPL-3 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
MICRO LABS LTD INDIA |
Labeling |
Approval |
| 04/16/2024 |
FINGOLIMOD HYDROCHLORIDE
ANDA #207979 |
SUPPL-6 |
FINGOLIMOD HYDROCHLORIDE |
BIOCON LTD |
Labeling |
Approval |
| 04/16/2024 |
TRANEXAMIC ACID
ANDA #216877 |
ORIG-1 |
TRANEXAMIC ACID |
NEXUS |
|
Approval |
| 04/16/2024 |
CETRORELIX ACETATE
ANDA #217776 |
ORIG-1 |
CETRORELIX ACETATE |
QILU |
|
Approval |
| 04/16/2024 |
TRANEXAMIC ACID
ANDA #218599 |
ORIG-1 |
TRANEXAMIC ACID |
GLAND PHARMA LTD |
|
Approval |
| 04/16/2024 |
SELARSDI
BLA #761343 |
ORIG-1 |
USTEKINUMAB-AEKN |
ALVOTECH USA INC |
|
Approval |
| 04/17/2024 |
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
ANDA #203978 |
ORIG-1 |
NICARDIPINE HYDROCHLORIDE |
INFORLIFE |
|
Approval |
| 04/17/2024 |
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
ANDA #203978 |
ORIG-1 |
NICARDIPINE HYDROCHLORIDE |
INFORLIFE |
|
Approval |
| 04/17/2024 |
PRASUGREL
ANDA #205897 |
SUPPL-2 |
PRASUGREL HYDROCHLORIDE |
PANACEA |
Labeling |
Approval |
| 04/17/2024 |
LUMISIGHT
NDA #214511 |
ORIG-1 |
PEGULICIANINE ACETATE |
LUMICELL |
Type 1 - New Molecular Entity |
Approval |
| 04/17/2024 |
LYTGOBI
NDA #214801 |
SUPPL-2 |
FUTIBATINIB |
TAIHO ONCOLOGY |
Labeling |
Approval |
| 04/17/2024 |
LEUCOVORIN CALCIUM
ANDA #216590 |
SUPPL-5 |
LEUCOVORIN CALCIUM |
KINDOS |
Labeling |
Approval |
| 04/17/2024 |
ERTUGLIFLOZIN
ANDA #217071 |
ORIG-1 |
ERTUGLIFLOZIN |
HETERO LABS |
|
Tentative Approval |
| 04/17/2024 |
METOLAZONE
ANDA #218606 |
ORIG-1 |
METOLAZONE |
LEADING |
|
Approval |
| 04/18/2024 |
ENTYVIO
BLA #125476 |
SUPPL-60 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
| 04/18/2024 |
ENTYVIO
BLA #125476 |
SUPPL-61 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
| 04/18/2024 |
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #203573 |
SUPPL-14 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/18/2024 |
METHAMPHETAMINE HYDROCHLORIDE
ANDA #203846 |
SUPPL-1 |
METHAMPHETAMINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/18/2024 |
METHAMPHETAMINE HYDROCHLORIDE
ANDA #203846 |
SUPPL-2 |
METHAMPHETAMINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/18/2024 |
METHAMPHETAMINE HYDROCHLORIDE
ANDA #203846 |
SUPPL-3 |
METHAMPHETAMINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/18/2024 |
METHAMPHETAMINE HYDROCHLORIDE
ANDA #203846 |
SUPPL-4 |
METHAMPHETAMINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/18/2024 |
METHAMPHETAMINE HYDROCHLORIDE
ANDA #203846 |
SUPPL-6 |
METHAMPHETAMINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 04/18/2024 |
TIVICAY
NDA #204790 |
SUPPL-31 |
DOLUTEGRAVIR SODIUM |
VIIV HLTHCARE |
Labeling |
Approval |
| 04/18/2024 |
TRIUMEQ
NDA #205551 |
SUPPL-32 |
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
| 04/18/2024 |
ALECENSA
NDA #208434 |
SUPPL-15 |
ALECTINIB HYDROCHLORIDE |
HOFFMANN-LA ROCHE |
Efficacy |
Approval |
| 04/18/2024 |
JULUCA
NDA #210192 |
SUPPL-14 |
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE |
VIIV HLTHCARE |
Labeling |
Approval |
| 04/18/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #211708 |
SUPPL-7 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
| 04/18/2024 |
OXYCODONE AND ACETAMINOPHEN
ANDA #211708 |
SUPPL-9 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
| 04/18/2024 |
DOVATO
NDA #211994 |
SUPPL-21 |
DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
| 04/18/2024 |
TIVICAY PD
NDA #213983 |
SUPPL-4 |
DOLUTEGRAVIR SODIUM |
VIIV HLTHCARE |
Labeling |
Approval |
| 04/18/2024 |
TRIUMEQ PD
NDA #215413 |
SUPPL-3 |
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
| 04/18/2024 |
FLEQSUVY
NDA #215602 |
SUPPL-3 |
BACLOFEN |
AZURITY |
Manufacturing (CMC) |
Approval |
| 04/18/2024 |
ELTROMBOPAG OLAMINE
ANDA #216620 |
ORIG-1 |
ELTROMBOPAG OLAMINE |
ANNORA PHARMA |
|
Approval |
| 04/18/2024 |
ENTYVIO
BLA #761133 |
SUPPL-5 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
| 04/18/2024 |
ENTYVIO
BLA #761133 |
SUPPL-6 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
| 04/18/2024 |
ENTYVIO
BLA #761359 |
ORIG-1 |
VEDOLIZUMAB |
TAKEDA PHARMS USA |
|
Approval |
| 04/19/2024 |
PERCODAN
NDA #007337 |
SUPPL-55 |
ASPIRIN; OXYCODONE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/19/2024 |
PERCODAN
NDA #007337 |
SUPPL-55 |
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/19/2024 |
PERCODAN-DEMI
NDA #007337 |
SUPPL-55 |
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/19/2024 |
CELEXA
NDA #020822 |
SUPPL-55 |
CITALOPRAM HYDROBROMIDE |
ABBVIE |
Labeling |
Approval |
| 04/19/2024 |
ROXICODONE
NDA #021011 |
SUPPL-14 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 04/19/2024 |
LOTRIMIN ULTRA
NDA #021307 |
SUPPL-23 |
BUTENAFINE HYDROCHLORIDE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 04/19/2024 |
LEXAPRO
NDA #021323 |
SUPPL-58 |
ESCITALOPRAM OXALATE |
ABBVIE |
Labeling |
Approval |
| 04/19/2024 |
LEXAPRO
NDA #021365 |
SUPPL-41 |
ESCITALOPRAM OXALATE |
ABBVIE |
Labeling |
Approval |
| 04/19/2024 |
VIIBRYD
NDA #022567 |
SUPPL-25 |
VILAZODONE HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
| 04/19/2024 |
OXYCODONE HYDROCHLORIDE
NDA #200534 |
SUPPL-14 |
OXYCODONE HYDROCHLORIDE |
GENUS LIFESCIENCES |
Labeling |
Approval |
| 04/19/2024 |
OXYCODONE HYDROCHLORIDE
NDA #200535 |
SUPPL-23 |
OXYCODONE HYDROCHLORIDE |
GENUS LIFESCIENCES |
Labeling |
Approval |
| 04/19/2024 |
OXYCODONE HYDROCHLORIDE
NDA #201194 |
SUPPL-19 |
OXYCODONE HYDROCHLORIDE |
VISTAPHARM LLC |
Labeling |
Approval |
| 04/19/2024 |
OXAYDO
NDA #202080 |
SUPPL-14 |
OXYCODONE HYDROCHLORIDE |
ZYLA |
Labeling |
Approval |
| 04/19/2024 |
FETZIMA
NDA #204168 |
SUPPL-12 |
LEVOMILNACIPRAN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
| 04/19/2024 |
ROXYBOND
NDA #209777 |
SUPPL-9 |
OXYCODONE HYDROCHLORIDE |
PROTEGA PHARMS |
Labeling |
Approval |
| 04/19/2024 |
SUBLOCADE
NDA #209819 |
SUPPL-29 |
BUPRENORPHINE |
INDIVIOR |
REMS |
Approval |
| 04/19/2024 |
REZENOPY
NDA #215487 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
SUMMIT BIOSCI |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/19/2024 |
LUMIFY PRESERVATIVE FREE
NDA #218424 |
ORIG-1 |
BRIMONIDINE TARTRATE |
BAUSCH AND LOMB INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 04/19/2024 |
HALOPERIDOL
ANDA #218789 |
ORIG-1 |
HALOPERIDOL |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/22/2024 |
EXTRANEAL
NDA #021321 |
SUPPL-38 |
ICODEXTRIN |
BAXTER HLTHCARE |
Labeling |
Approval |
| 04/22/2024 |
ESTRADIOL
ANDA #216160 |
ORIG-1 |
ESTRADIOL |
SOLARIS PHARMA CORP |
|
Approval |
| 04/22/2024 |
ENZALUTAMIDE
ANDA #218187 |
ORIG-1 |
ENZALUTAMIDE |
TEVA PHARMS INC |
|
Tentative Approval |
| 04/22/2024 |
MINOXIDIL (FOR MEN)
ANDA #218616 |
ORIG-1 |
MINOXIDIL |
AUROBINDO PHARMA |
|
Approval |
| 04/22/2024 |
MINOXIDIL (FOR WOMEN)
ANDA #218616 |
ORIG-1 |
MINOXIDIL |
AUROBINDO PHARMA |
|
Approval |
| 04/22/2024 |
TECENTRIQ
BLA #761034 |
SUPPL-53 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 04/22/2024 |
IMFINZI
BLA #761069 |
SUPPL-48 |
DURVALUMAB |
ASTRAZENECA UK LTD |
|
Approval |
| 04/22/2024 |
LOQTORZI
BLA #761240 |
SUPPL-1 |
TORIPALIMAB-TPZI |
COHERUS BIOSCIENCES INC |
|
Approval |
| 04/22/2024 |
ZYNYZ
BLA #761334 |
SUPPL-2 |
RETIFANLIMAB-DLWR |
INCYTE CORP |
|
Approval |
| 04/22/2024 |
ANKTIVA
BLA #761336 |
ORIG-1 |
nogapendekin alfa inbakicept-pmln |
ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU |
|
Approval |
| 04/23/2024 |
CAMBIA
NDA #022165 |
SUPPL-6 |
DICLOFENAC POTASSIUM |
ASSERTIO |
Labeling |
Approval |
| 04/23/2024 |
AMOXICILLIN
ANDA #062927 |
SUPPL-26 |
AMOXICILLIN |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/23/2024 |
AMOXICILLIN
ANDA #062927 |
SUPPL-27 |
AMOXICILLIN |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/23/2024 |
AMOXICILLIN
ANDA #062927 |
SUPPL-28 |
AMOXICILLIN |
ENDO OPERATIONS |
Labeling |
Approval |
| 04/23/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065191 |
SUPPL-32 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
HIKMA PHARMS |
Labeling |
Approval |
| 04/23/2024 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-15 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 04/23/2024 |
RABEPRAZOLE SODIUM
ANDA #202376 |
SUPPL-20 |
RABEPRAZOLE SODIUM |
TORRENT |
Labeling |
Approval |
| 04/23/2024 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-7 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 04/23/2024 |
GLEOLAN
NDA #208630 |
SUPPL-7 |
AMINOLEVULINIC ACID HYDROCHLORIDE |
NXDC |
Labeling |
Approval |
| 04/23/2024 |
LUTATHERA
NDA #208700 |
SUPPL-31 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Efficacy |
Approval |
| 04/23/2024 |
ATORVALIQ
NDA #213260 |
SUPPL-2 |
ATORVASTATIN CALCIUM |
CMP DEV LLC |
Labeling |
Approval |
| 04/23/2024 |
VERAPAMIL HYDROCHLORIDE
ANDA #216471 |
ORIG-1 |
VERAPAMIL HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 04/23/2024 |
PANTOPRAZOLE SODIUM
ANDA #217416 |
SUPPL-2 |
PANTOPRAZOLE SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 04/23/2024 |
MOMETASONE FUROATE
ANDA #217438 |
ORIG-1 |
MOMETASONE FUROATE |
APOTEX |
|
Approval |
| 04/23/2024 |
OJEMDA
NDA #217700 |
ORIG-1 |
TOVORAFENIB |
DAY ONE BIOPHARMS |
Type 1 - New Molecular Entity |
Approval |
| 04/23/2024 |
NALOXONE HYDROCHLORIDE
ANDA #217992 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
AMNEAL |
|
Approval |
| 04/23/2024 |
OJEMDA
NDA #218033 |
ORIG-1 |
TOVORAFENIB |
DAY ONE BIOPHARMS |
Type 1 - New Molecular Entity |
Approval |
| 04/23/2024 |
PAZOPANIB HYDROCHLORIDE
ANDA #218231 |
ORIG-1 |
PAZOPANIB HYDROCHLORIDE |
NOVUGEN |
|
Approval |
| 04/24/2024 |
AMPICILLIN TRIHYDRATE
ANDA #061502 |
SUPPL-138 |
AMPICILLIN/AMPICILLIN TRIHYDRATE |
CHARTWELL RX |
Labeling |
Approval |
| 04/24/2024 |
AMPICILLIN TRIHYDRATE
ANDA #061502 |
SUPPL-139 |
AMPICILLIN/AMPICILLIN TRIHYDRATE |
CHARTWELL RX |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065089 |
SUPPL-21 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065089 |
SUPPL-26 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096 |
SUPPL-33 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096 |
SUPPL-36 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA PHARMS USA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065101 |
SUPPL-32 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065101 |
SUPPL-35 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205 |
SUPPL-19 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205 |
SUPPL-26 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065363 |
SUPPL-39 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/24/2024 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065363 |
SUPPL-40 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 04/24/2024 |
AMPICILLIN SODIUM
ANDA #065499 |
SUPPL-11 |
AMPICILLIN SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 04/24/2024 |
NORTRIPTYLINE HYDROCHLORIDE
ANDA #074132 |
SUPPL-31 |
NORTRIPTYLINE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 04/24/2024 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202770 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/24/2024 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202770 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/24/2024 |
CLINOLIPID 20%
NDA #204508 |
SUPPL-22 |
OLIVE OIL; SOYBEAN OIL |
BAXTER HLTHCARE CORP |
Efficacy |
Approval |
| 04/24/2024 |
BIKTARVY
NDA #210251 |
SUPPL-19 |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 04/24/2024 |
CETRORELIX ACETATE
ANDA #214540 |
ORIG-1 |
CETRORELIX ACETATE |
LIVZON GRP |
|
Approval |
| 04/24/2024 |
LACOSAMIDE
ANDA #214695 |
SUPPL-2 |
LACOSAMIDE |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/24/2024 |
LACOSAMIDE
ANDA #214695 |
SUPPL-4 |
LACOSAMIDE |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/24/2024 |
LACOSAMIDE
ANDA #214695 |
SUPPL-6 |
LACOSAMIDE |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/24/2024 |
LACOSAMIDE
ANDA #214695 |
SUPPL-7 |
LACOSAMIDE |
ALKEM LABS LTD |
Labeling |
Approval |
| 04/24/2024 |
VIJOICE
NDA #215039 |
SUPPL-2 |
ALPELISIB |
NOVARTIS |
Efficacy |
Approval |
| 04/24/2024 |
LOTEPREDNOL ETABONATE
ANDA #215719 |
ORIG-1 |
LOTEPREDNOL ETABONATE |
LUPIN LTD |
|
Approval |
| 04/24/2024 |
PIVYA
NDA #216483 |
ORIG-1 |
PIVMECILLINAM HYDROCHLORIDE |
UTILITY THERAP |
Type 2 - New Active Ingredient |
Approval |
| 04/24/2024 |
VIJOICE
NDA #218466 |
ORIG-1 |
ALPELISIB |
NOVARTIS |
Type 3 - New Dosage Form |
Approval |
| 04/24/2024 |
FENOFIBRATE
ANDA #218548 |
ORIG-1 |
FENOFIBRATE |
YICHANG HUMANWELL |
|
Approval |
| 04/25/2024 |
TRANDATE
NDA #018716 |
SUPPL-36 |
LABETALOL HYDROCHLORIDE |
ALVOGEN |
Labeling |
Approval |
| 04/25/2024 |
ZINC CHLORIDE IN PLASTIC CONTAINER
NDA #018959 |
SUPPL-32 |
ZINC CHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 04/25/2024 |
GALZIN
NDA #020458 |
SUPPL-9 |
ZINC ACETATE |
TEVA |
Labeling |
Approval |
| 04/25/2024 |
DIGOXIN
NDA #021648 |
SUPPL-15 |
DIGOXIN |
HIKMA |
Labeling |
Approval |
| 04/25/2024 |
AMRIX
NDA #021777 |
SUPPL-19 |
CYCLOBENZAPRINE HYDROCHLORIDE |
TEVA PHARMS INTL |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #062881 |
SUPPL-26 |
AMOXICILLIN |
STRIDES PHARMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #062881 |
SUPPL-27 |
AMOXICILLIN |
STRIDES PHARMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #062881 |
SUPPL-28 |
AMOXICILLIN |
STRIDES PHARMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #062884 |
SUPPL-23 |
AMOXICILLIN |
STRIDES PHARMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #062884 |
SUPPL-24 |
AMOXICILLIN |
STRIDES PHARMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #062884 |
SUPPL-25 |
AMOXICILLIN |
STRIDES PHARMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #064076 |
SUPPL-37 |
AMOXICILLIN |
SANDOZ |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #064139 |
SUPPL-13 |
AMOXICILLIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #064139 |
SUPPL-14 |
AMOXICILLIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #064139 |
SUPPL-15 |
AMOXICILLIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065228 |
SUPPL-17 |
AMOXICILLIN |
SANDOZ |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065228 |
SUPPL-19 |
AMOXICILLIN |
SANDOZ |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065255 |
SUPPL-25 |
AMOXICILLIN |
HIKMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065325 |
SUPPL-32 |
AMOXICILLIN |
HIKMA |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065344 |
SUPPL-5 |
AMOXICILLIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065344 |
SUPPL-6 |
AMOXICILLIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065344 |
SUPPL-7 |
AMOXICILLIN |
CHARTWELL RX |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065378 |
SUPPL-18 |
AMOXICILLIN |
SANDOZ |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN
ANDA #065387 |
SUPPL-18 |
AMOXICILLIN |
SANDOZ |
Labeling |
Approval |
| 04/25/2024 |
VIORELE
ANDA #091346 |
SUPPL-16 |
DESOGESTREL; ETHINYL ESTRADIOL |
GLENMARK PHARMS LTD |
Manufacturing (CMC) |
Approval |
| 04/25/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201090 |
SUPPL-5 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/25/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201090 |
SUPPL-11 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 04/25/2024 |
BRINZOLAMIDE
ANDA #204884 |
SUPPL-7 |
BRINZOLAMIDE |
BAUSCH AND LOMB |
Labeling |
Approval |
| 04/25/2024 |
OTEZLA
NDA #205437 |
SUPPL-13 |
APREMILAST |
AMGEN INC |
Efficacy |
Approval |
| 04/25/2024 |
SEVELAMER CARBONATE
ANDA #207291 |
ORIG-1 |
SEVELAMER CARBONATE |
MACLEODS PHARMS LTD |
|
Approval |
| 04/25/2024 |
ESLICARBAZEPINE ACETATE
ANDA #211247 |
ORIG-1 |
ESLICARBAZEPINE ACETATE |
SPH SHANGHAI ZHONGXI PHARMA CO LTD |
|
Tentative Approval |
| 04/25/2024 |
SAFINAMIDE MESYLATE
ANDA #215739 |
ORIG-1 |
SAFINAMIDE MESYLATE |
PRINSTON INC |
|
Approval |
| 04/25/2024 |
DEFLAZACORT
ANDA #217813 |
ORIG-1 |
DEFLAZACORT |
TRIS PHARMA INC |
|
Approval |
| 04/25/2024 |
CETRORELIX ACETATE
ANDA #218150 |
ORIG-1 |
CETRORELIX ACETATE |
GLAND |
|
Approval |
| 04/25/2024 |
DIAZEPAM
ANDA #218450 |
ORIG-1 |
DIAZEPAM |
ALEMBIC |
|
Approval |
| 04/25/2024 |
TRETINOIN
ANDA #218561 |
ORIG-1 |
TRETINOIN |
ZYDUS LIFESCIENCES |
|
Approval |
| 04/25/2024 |
HERCESSI
BLA #761346 |
ORIG-1 |
TRASTUZUMAB-STRF |
ACCORD BIOPHARMA INC. |
|
Approval |
| 04/26/2024 |
CLINDAMYCIN PHOSPHATE
ANDA #064050 |
SUPPL-24 |
CLINDAMYCIN PHOSPHATE |
PADAGIS US |
Manufacturing (CMC) |
Approval |
| 04/26/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065162 |
SUPPL-29 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/26/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065162 |
SUPPL-32 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/26/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065162 |
SUPPL-36 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
TEVA |
Labeling |
Approval |
| 04/26/2024 |
RINVOQ
NDA #211675 |
SUPPL-21 |
UPADACITINIB |
ABBVIE |
Efficacy |
Approval |
| 04/26/2024 |
RINVOQ
NDA #211675 |
SUPPL-22 |
UPADACITINIB |
ABBVIE |
Efficacy |
Approval |
| 04/26/2024 |
ZILBRYSQ
NDA #216834 |
SUPPL-1 |
ZILUCOPLAN SODIUM |
UCB INC |
Labeling |
Approval |
| 04/26/2024 |
BINIMETINIB
ANDA #217678 |
ORIG-1 |
BINIMETINIB |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 04/26/2024 |
ACETAMINOPHEN AND IBUPROFEN
ANDA #218311 |
ORIG-1 |
ACETAMINOPHEN; IBUPROFEN |
GLENMARK PHARMS LTD |
|
Approval |
| 04/26/2024 |
RINVOQ
NDA #218347 |
ORIG-1 |
UPADACITINIB |
ABBVIE |
Type 3 - New Dosage Form |
Approval |
| 04/26/2024 |
RINVOQ LQ
NDA #218347 |
ORIG-1 |
UPADACITINIB |
ABBVIE |
Type 3 - New Dosage Form |
Approval |
| 04/26/2024 |
LIBERVANT
NDA #218623 |
ORIG-1 |
DIAZEPAM |
AQUESTIVE |
Type 3 - New Dosage Form |
Approval |
| 04/26/2024 |
XOLREMDI
NDA #218709 |
ORIG-1 |
MAVORIXAFOR |
X4 PHARMS |
Type 1 - New Molecular Entity |
Approval |
| 04/29/2024 |
LANOXIN
NDA #020405 |
SUPPL-17 |
DIGOXIN |
CONCORDIA |
Labeling |
Approval |
| 04/29/2024 |
TRUVADA
NDA #021752 |
SUPPL-64 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD |
Labeling |
Approval |
| 04/29/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065063 |
SUPPL-48 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065064 |
SUPPL-47 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065065 |
SUPPL-34 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065066 |
SUPPL-45 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065189 |
SUPPL-28 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 04/29/2024 |
TAGRISSO
NDA #208065 |
SUPPL-31 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Labeling |
Approval |
| 04/29/2024 |
COLCHICINE
ANDA #210757 |
ORIG-1 |
COLCHICINE |
GRANULES |
|
Approval |
| 04/29/2024 |
EZETIMIBE
ANDA #211159 |
ORIG-1 |
EZETIMIBE |
MACLEODS PHARMS LTD |
|
Approval |
| 04/29/2024 |
GIVLAARI
NDA #212194 |
SUPPL-7 |
GIVOSIRAN SODIUM |
ALNYLAM PHARMS INC |
Labeling |
Approval |
| 04/29/2024 |
LUPKYNIS
NDA #213716 |
SUPPL-4 |
VOCLOSPORIN |
AURINIA |
Efficacy |
Approval |
| 04/29/2024 |
DARUNAVIR; COBICISTAT
ANDA #215036 |
ORIG-1 |
DARUNAVIR;COBICISTAT |
MYLAN PHARMS INC |
|
Tentative Approval |
| 04/29/2024 |
COLCHICINE
ANDA #215463 |
ORIG-1 |
COLCHICINE |
AUROBINDO PHARMA LTD |
|
Approval |
| 04/29/2024 |
MIDOSTAURIN
ANDA #216076 |
ORIG-1 |
MIDOSTAURIN |
TEVA PHARMS |
|
Approval |
| 04/29/2024 |
COLCHICINE
ANDA #217620 |
ORIG-1 |
COLCHICINE |
ANNORA PHARMA |
|
Approval |
| 04/29/2024 |
ATROPINE SULFATE
ANDA #217791 |
ORIG-1 |
ATROPINE SULFATE |
SOMERSET |
|
Approval |
| 04/29/2024 |
TRETINOIN
ANDA #217804 |
ORIG-1 |
TRETINOIN |
ALEMBIC |
|
Approval |
| 04/29/2024 |
LIDOCAINE HYDROCHLORIDE
ANDA #218411 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
THE J MOLNER |
|
Approval |
| 04/29/2024 |
BESREMI
BLA #761166 |
SUPPL-7 |
ROPEGINTERFERON ALFA-2B-NJFT |
PHARMAESSENTIA CORP |
|
Approval |
| 04/29/2024 |
TIVDAK
BLA #761208 |
SUPPL-7 |
TISOTUMAB VEDOTIN-TFTV |
SEAGEN |
|
Approval |
| 04/29/2024 |
OMVOH
BLA #761279 |
SUPPL-1 |
MIRIKIZUMAB-MRKZ |
ELI LILLY AND CO |
|
Approval |
| 04/30/2024 |
NICORETTE
NDA #022360 |
SUPPL-17 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
| 04/30/2024 |
MEPERIDINE HYDROCHLORIDE
ANDA #040186 |
SUPPL-13 |
MEPERIDINE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 04/30/2024 |
URSODIOL
ANDA #075517 |
SUPPL-18 |
URSODIOL |
EPIC PHARMA |
Labeling |
Approval |
| 04/30/2024 |
NICOTINE POLACRILEX
ANDA #076778 |
SUPPL-19 |
NICOTINE POLACRILEX |
L PERRIGO CO |
Labeling |
Approval |
| 04/30/2024 |
SOTALOL HYDROCHLORIDE
ANDA #077616 |
SUPPL-5 |
SOTALOL HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 04/30/2024 |
SOTALOL HYDROCHLORIDE
ANDA #077616 |
SUPPL-8 |
SOTALOL HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 04/30/2024 |
MEPERIDINE HYDROCHLORIDE
ANDA #080448 |
SUPPL-23 |
MEPERIDINE HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 04/30/2024 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #090227 |
SUPPL-18 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 04/30/2024 |
EPOGEN/PROCRIT
BLA #103234 |
SUPPL-5378 |
EPOETIN ALFA |
AMGEN |
|
Approval |
| 04/30/2024 |
ARANESP
BLA #103951 |
SUPPL-5383 |
DARBEPOETIN ALFA |
AMGEN |
|
Approval |
| 04/30/2024 |
MIRCERA
BLA #125164 |
SUPPL-89 |
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA |
HOFFMAN-LA ROCHE |
|
Approval |
| 04/30/2024 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201662 |
SUPPL-26 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
ALEMBIC |
Labeling |
Approval |
| 04/30/2024 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845 |
SUPPL-20 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
JUBILANT CADISTA |
Labeling |
Approval |
| 04/30/2024 |
HYDROCHLOROTHIAZIDE
ANDA #202556 |
SUPPL-8 |
HYDROCHLOROTHIAZIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 04/30/2024 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/30/2024 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742 |
SUPPL-12 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
| 04/30/2024 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203000 |
SUPPL-1 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 04/30/2024 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203000 |
SUPPL-2 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 04/30/2024 |
HYDROCHLOROTHIAZIDE
ANDA #203561 |
SUPPL-3 |
HYDROCHLOROTHIAZIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 04/30/2024 |
HYDROCHLOROTHIAZIDE
ANDA #203561 |
SUPPL-5 |
HYDROCHLOROTHIAZIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 04/30/2024 |
LINEZOLID
ANDA #204536 |
SUPPL-7 |
LINEZOLID |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/30/2024 |
LINEZOLID
ANDA #204536 |
SUPPL-8 |
LINEZOLID |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/30/2024 |
LINEZOLID
ANDA #204536 |
SUPPL-9 |
LINEZOLID |
AMNEAL PHARMS |
Labeling |
Approval |
| 04/30/2024 |
PITAVASTATIN CALCIUM
ANDA #205977 |
ORIG-1 |
PITAVASTATIN CALCIUM |
HETERO LABS LTD V |
|
Approval |
| 04/30/2024 |
EVEROLIMUS
ANDA #206133 |
SUPPL-6 |
EVEROLIMUS |
HIKMA |
Labeling |
Approval |
| 04/30/2024 |
SEVELAMER CARBONATE
ANDA #207179 |
SUPPL-11 |
SEVELAMER CARBONATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 04/30/2024 |
ESOMEPRAZOLE MAGNESIUM
ANDA #207198 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
DR REDDYS |
|
Approval |
| 04/30/2024 |
EZETIMIBE
ANDA #207311 |
SUPPL-12 |
EZETIMIBE |
OHM LABS INC |
Labeling |
Approval |
| 04/30/2024 |
HYDROCORTISONE BUTYRATE
ANDA #209556 |
SUPPL-4 |
HYDROCORTISONE BUTYRATE |
THE J MOLNER |
Labeling |
Approval |
| 04/30/2024 |
DIMETHYL FUMARATE
ANDA #210531 |
SUPPL-3 |
DIMETHYL FUMARATE |
MYLAN |
Labeling |
Approval |
| 04/30/2024 |
DIMETHYL FUMARATE
ANDA #210531 |
SUPPL-6 |
DIMETHYL FUMARATE |
MYLAN |
Labeling |
Approval |
| 04/30/2024 |
DIMETHYL FUMARATE
ANDA #210531 |
SUPPL-10 |
DIMETHYL FUMARATE |
MYLAN |
Labeling |
Approval |
| 04/30/2024 |
DIMETHYL FUMARATE
ANDA #210531 |
SUPPL-12 |
DIMETHYL FUMARATE |
MYLAN |
Labeling |
Approval |
| 04/30/2024 |
DIMETHYL FUMARATE
ANDA #210531 |
SUPPL-13 |
DIMETHYL FUMARATE |
MYLAN |
Labeling |
Approval |
| 04/30/2024 |
BROMFENAC SODIUM
ANDA #210962 |
ORIG-1 |
BROMFENAC SODIUM |
AMNEAL PHARMS CO |
|
Tentative Approval |
| 04/30/2024 |
DOFETILIDE
ANDA #212750 |
SUPPL-2 |
DOFETILIDE |
GRANULES |
Labeling |
Approval |
| 04/30/2024 |
ELTROMBOPAG
ANDA #212884 |
ORIG-1 |
ELTROMBOPAG |
AMNEAL EU LTD |
|
Tentative Approval |
| 04/30/2024 |
MYFEMBREE
NDA #214846 |
SUPPL-7 |
ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX |
MYOVANT SCIENCES |
Efficacy |
Approval |
| 04/30/2024 |
CAMZYOS
NDA #214998 |
SUPPL-9 |
MAVACAMTEN |
BRISTOL |
Labeling |
Approval |
| 04/30/2024 |
CUPRIC CHLORIDE
ANDA #216113 |
ORIG-1 |
CUPRIC CHLORIDE |
SOMERSET |
|
Approval |
| 04/30/2024 |
CUPRIC CHLORIDE
ANDA #217626 |
ORIG-1 |
CUPRIC CHLORIDE |
RK PHARMA |
|
Approval |
| 04/30/2024 |
VASOPRESSIN IN SODIUM CHLORIDE INJECTION
NDA #217766 |
ORIG-1 |
VASOPRESSIN |
LONG GROVE PHARMS |
Type 3 - New Dosage Form |
Tentative Approval |
| 04/30/2024 |
INGREZZA SPRINKLE
NDA #218390 |
ORIG-1 |
VALBENAZINE TOSYLATE |
NEUROCRINE |
|
Approval |
| 04/30/2024 |
CYLTEZO
BLA #761058 |
SUPPL-26 |
ADALIMUMAB-ADBM |
BOEHRINGER INGELHEIM |
|
Approval |
| 04/30/2024 |
ABRILADA
BLA #761118 |
SUPPL-12 |
ADALIMUMAB-AFZB |
PFIZER INC |
|
Approval |
