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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
June 2024

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on June 15, 2024.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/03/2024 ATENOLOL AND CHLORTHALIDONE
ANDA #073665		 SUPPL-47 ATENOLOL; CHLORTHALIDONE WATSON LABS Labeling Approval
06/03/2024 METOPROLOL TARTRATE
ANDA #076704		 SUPPL-41 METOPROLOL TARTRATE MYLAN Labeling Approval
06/03/2024 METOPROLOL TARTRATE
ANDA #076704		 SUPPL-45 METOPROLOL TARTRATE MYLAN Labeling Approval
06/03/2024 CITALOPRAM HYDROBROMIDE
ANDA #077046		 SUPPL-24 CITALOPRAM HYDROBROMIDE APOTEX Labeling Approval
06/03/2024 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-22 DIVALPROEX SODIUM APOTEX Labeling Approval
06/03/2024 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-33 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
06/03/2024 EZETIMIBE
ANDA #078560		 SUPPL-11 EZETIMIBE GLENMARK PHARMS LTD Labeling Approval
06/03/2024 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-29 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
06/03/2024 ARMODAFINIL
ANDA #202768		 SUPPL-6 ARMODAFINIL NATCO PHARMA LTD Labeling Approval
06/03/2024 METHYLPHENIDATE HYDROCHLORIDE
ANDA #206840		 SUPPL-6 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Labeling Approval
06/03/2024 METHYLPHENIDATE HYDROCHLORIDE
ANDA #206932		 SUPPL-14 METHYLPHENIDATE HYDROCHLORIDE ABHAI INC Labeling Approval
06/03/2024 ATORVASTATIN CALCIUM
ANDA #208480		 ORIG-1 ATORVASTATIN CALCIUM MACLEODS PHARMS LTD Approval
06/03/2024 TPOXX
NDA #208627		 SUPPL-8 TECOVIRIMAT SIGA TECHNOLOGIES Labeling Approval
06/03/2024 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #209010		 SUPPL-7 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL SCIEGEN PHARMS INC Labeling Approval
06/03/2024 EZETIMIBE
ANDA #209838		 SUPPL-11 EZETIMIBE AUROBINDO PHARMA Labeling Approval
06/03/2024 METHYLPHENIDATE HYDROCHLORIDE
ANDA #210818		 SUPPL-4 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Labeling Approval
06/03/2024 RUFINAMIDE
ANDA #213410		 SUPPL-2 RUFINAMIDE ALKEM LABS LTD Labeling Approval
06/03/2024 TAVNEOS
NDA #214487		 SUPPL-4 AVACOPAN CHEMOCENTRYX Labeling Approval
06/03/2024 TPOXX
NDA #214518		 SUPPL-3 TECOVIRIMAT SIGA TECHNOLOGIES Labeling Approval
06/03/2024 DIVALPROEX SODIUM
ANDA #214643		 SUPPL-4 DIVALPROEX SODIUM UNICHEM Labeling Approval
06/03/2024 METHYLPREDNISOLONE ACETATE
ANDA #214870		 SUPPL-6 METHYLPREDNISOLONE ACETATE SLAYBACK PHARMA LLC Labeling Approval
06/03/2024 ARFORMOTEROL TARTRATE
ANDA #215032		 ORIG-1 ARFORMOTEROL TARTRATE DR REDDYS Approval
06/03/2024 METHOTREXATE SODIUM
ANDA #217552		 ORIG-1 METHOTREXATE SODIUM ALEMBIC Approval
06/03/2024 TOFACITINIB
ANDA #218462		 ORIG-1 TOFACITINIB CITRATE AUROBINDO PHARMA LTD Approval
06/04/2024 CETROTIDE
NDA #021197		 SUPPL-30 CETRORELIX ACETATE EMD SERONO INC Labeling Approval
06/04/2024 DEXAMETHASONE
ANDA #040700		 SUPPL-6 DEXAMETHASONE BAUSCH Labeling Approval
06/04/2024 METFORMIN HYDROCHLORIDE
ANDA #075973		 SUPPL-36 METFORMIN HYDROCHLORIDE MYLAN Manufacturing (CMC) Approval
06/04/2024 MIRCERA
BLA #125164		 SUPPL-91 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA HOFFMAN-LA ROCHE Approval
06/04/2024 RETACRIT
BLA #125545		 SUPPL-32 EPOETIN ALFA-EPBX HOSPIRA INC Approval
06/04/2024 ALENDRONATE SODIUM
ANDA #206387		 ORIG-1 ALENDRONATE SODIUM IPCA LABS LTD Approval
06/04/2024 TERIFLUNOMIDE
ANDA #209710		 SUPPL-5 TERIFLUNOMIDE SANDOZ Manufacturing (CMC) Approval
06/04/2024 PERAMPANEL
ANDA #209801		 ORIG-1 PERAMPANEL TEVA PHARMS USA INC Tentative Approval
06/04/2024 VYONDYS 53
NDA #211970		 SUPPL-10 GOLODIRSEN SAREPTA THERAPS INC Labeling Approval
06/04/2024 VYONDYS 53
NDA #211970		 SUPPL-11 GOLODIRSEN SAREPTA THERAPS INC Labeling Approval
06/04/2024 BRUKINSA
NDA #213217		 SUPPL-14 ZANUBRUTINIB BEIGENE Labeling Approval
06/04/2024 ESMOLOL HYDROCHLORIDE
ANDA #214172		 SUPPL-2 ESMOLOL HYDROCHLORIDE HQ SPCLT PHARMA Labeling Approval
06/04/2024 BRIVARACETAM
ANDA #214848		 SUPPL-1 BRIVARACETAM AUROBINDO PHARMA LTD Labeling Approval
06/04/2024 LIFITEGRAST
ANDA #215058		 ORIG-1 LIFITEGRAST INGENUS PHARMS LLC Tentative Approval
06/04/2024 JAYPIRCA
NDA #216059		 SUPPL-2 PIRTOBRUTINIB LOXO ONCOL Labeling Approval
06/04/2024 LISDEXAMFETAMINE DIMESYLATE
ANDA #216266		 SUPPL-1 LISDEXAMFETAMINE DIMESYLATE PRINSTON INC Labeling Approval
06/04/2024 DEXAMETHASONE
ANDA #217001		 SUPPL-1 DEXAMETHASONE BIONPHARMA Labeling Approval
06/04/2024 CARBIDOPA AND LEVODOPA
ANDA #217482		 ORIG-1 CARBIDOPA; LEVODOPA RUBICON Approval
06/04/2024 LOSARTAN POTASSIUM
ANDA #218551		 ORIG-1 LOSARTAN POTASSIUM APOTEX Approval
06/04/2024 TERIPARATIDE
NDA #218771		 ORIG-1 TERIPARATIDE ALMAJECT Type 5 - New Formulation or New Manufacturer Approval
06/04/2024 IDACIO
BLA #761255		 SUPPL-6 ADALIMUMAB-AACF FRESENIUS KABI USA Approval
06/05/2024 CORTEF
NDA #008697		 SUPPL-40 HYDROCORTISONE PHARMACIA AND UPJOHN Labeling Approval
06/05/2024 SOLU-CORTEF
NDA #009866		 SUPPL-121 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
06/05/2024 MEDROL
NDA #011153		 SUPPL-83 METHYLPREDNISOLONE PFIZER Labeling Approval
06/05/2024 ARISTOCORT
NDA #011685		 SUPPL-27 TRIAMCINOLONE DIACETATE FOSUN PHARMA Labeling Approval
06/05/2024 DEPO-MEDROL
NDA #011757		 SUPPL-125 METHYLPREDNISOLONE ACETATE PFIZER Labeling Approval
06/05/2024 SOLU-MEDROL
NDA #011856		 SUPPL-144 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
06/05/2024 KENALOG-10
NDA #012041		 SUPPL-51 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
06/05/2024 HEXADROL
NDA #012674		 SUPPL-10 DEXAMETHASONE ASPEN GLOBAL INC Labeling Approval
06/05/2024 HEXADROL
NDA #012675		 SUPPL-15 DEXAMETHASONE ASPEN GLOBAL INC Labeling Approval
06/05/2024 ARISTOCORT
NDA #012802		 SUPPL-34 TRIAMCINOLONE DIACETATE FOSUN PHARMA Labeling Approval
06/05/2024 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-68 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON Labeling Approval
06/05/2024 HEXADROL
NDA #014694		 SUPPL-31 DEXAMETHASONE SODIUM PHOSPHATE ASPEN GLOBAL INC Labeling Approval
06/05/2024 KENALOG-40
NDA #014901		 SUPPL-54 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
06/05/2024 KENALOG-80
NDA #014901		 SUPPL-54 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
06/05/2024 ARISTOSPAN
NDA #016466		 SUPPL-47 TRIAMCINOLONE HEXACETONIDE SANDOZ Labeling Approval
06/05/2024 PEDIAPRED
NDA #019157		 SUPPL-25 PREDNISOLONE SODIUM PHOSPHATE SETON PHARM Labeling Approval
06/05/2024 ENTOCORT EC
NDA #021324		 SUPPL-27 BUDESONIDE PADAGIS US Labeling Approval
06/05/2024 ORAPRED ODT
NDA #021959		 SUPPL-14 PREDNISOLONE SODIUM PHOSPHATE CONCORDIA PHARMS INC Labeling Approval
06/05/2024 FLO-PRED
NDA #022067		 SUPPL-15 PREDNISOLONE ACETATE TARO Labeling Approval
06/05/2024 GILENYA
NDA #022527		 SUPPL-42 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
06/05/2024 PREDNISONE
ANDA #040256		 SUPPL-24 PREDNISONE ENDO OPERATIONS Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040322		 SUPPL-3 PREDNISOLONE TEVA PHARMS Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040323		 SUPPL-10 PREDNISOLONE CHARTWELL RX Labeling Approval
06/05/2024 PREDNISONE
ANDA #040362		 SUPPL-20 PREDNISONE JUBILANT CADISTA Labeling Approval
06/05/2024 PREDNISONE
ANDA #040392		 SUPPL-19 PREDNISONE ENDO OPERATIONS Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040399		 SUPPL-4 PREDNISOLONE PHARM ASSOC Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040401		 SUPPL-15 PREDNISOLONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #040491		 SUPPL-15 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
06/05/2024 PREDNISONE
ANDA #040538		 SUPPL-7 PREDNISONE HIKMA PHARMS Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040570		 SUPPL-3 PREDNISOLONE PHARM ASSOC Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040571		 SUPPL-4 PREDNISOLONE PHARM ASSOC Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040572		 SUPPL-9 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
06/05/2024 PREDNISONE
ANDA #040581		 SUPPL-23 PREDNISONE ENDO OPERATIONS Labeling Approval
06/05/2024 PREDNISONE
ANDA #040584		 SUPPL-22 PREDNISONE ENDO OPERATIONS Labeling Approval
06/05/2024 PREDNISONE
ANDA #040611		 SUPPL-15 PREDNISONE JUBILANT CADISTA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #040700		 SUPPL-7 DEXAMETHASONE BAUSCH Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #040775		 SUPPL-13 PREDNISOLONE LANNETT CO INC Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040802		 SUPPL-21 DEXAMETHASONE SODIUM PHOSPHATE MYLAN LABS LTD Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040803		 SUPPL-29 DEXAMETHASONE SODIUM PHOSPHATE MYLAN LABS LTD Labeling Approval
06/05/2024 PREDNISONE
ANDA #040890		 SUPPL-7 PREDNISONE HIKMA PHARMS Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #075183		 SUPPL-7 PREDNISOLONE SODIUM PHOSPHATE HIKMA Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #075988		 SUPPL-10 PREDNISOLONE SODIUM PHOSPHATE CHARTWELL RX Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #076123		 SUPPL-2 PREDNISOLONE SODIUM PHOSPHATE PHARM ASSOC Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #076895		 SUPPL-19 PREDNISOLONE SODIUM PHOSPHATE XTTRIUM LABS INC Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #076913		 SUPPL-14 PREDNISOLONE SODIUM PHOSPHATE PHARM ASSOC Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #078465		 SUPPL-8 PREDNISOLONE SODIUM PHOSPHATE PHARM ASSOC Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #078988		 SUPPL-11 PREDNISOLONE SODIUM PHOSPHATE PHARM ASSOC Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #079010		 SUPPL-3 PREDNISOLONE SODIUM PHOSPHATE ENDO OPERATIONS Labeling Approval
06/05/2024 PREDNISONE
ANDA #080292		 SUPPL-64 PREDNISONE MYLAN Labeling Approval
06/05/2024 PREDNISONE
ANDA #080336		 SUPPL-50 PREDNISONE SANDOZ Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #080339		 SUPPL-50 PREDNISOLONE FOSUN PHARMA Labeling Approval
06/05/2024 PREDNISONE
ANDA #080352		 SUPPL-74 PREDNISONE HIKMA Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #080354		 SUPPL-72 PREDNISOLONE WATSON LABS Labeling Approval
06/05/2024 PREDNISONE
ANDA #080356		 SUPPL-116 PREDNISONE WATSON LABS Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #080399		 SUPPL-80 DEXAMETHASONE PRASCO Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #080531		 SUPPL-15 PREDNISOLONE CHARTWELL MOLECULAR Labeling Approval
06/05/2024 CORTISONE ACETATE
ANDA #080694		 SUPPL-8 CORTISONE ACETATE CHARTWELL MOLECULAR Labeling Approval
06/05/2024 CORTISONE ACETATE
ANDA #080776		 SUPPL-53 CORTISONE ACETATE HIKMA INTL PHARMS Labeling Approval
06/05/2024 PREDNISONE
ANDA #083677		 SUPPL-69 PREDNISONE MYLAN Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084013		 SUPPL-30 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084081		 SUPPL-49 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084084		 SUPPL-27 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084086		 SUPPL-29 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 PREDNISONE
ANDA #084122		 SUPPL-60 PREDNISONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084282		 SUPPL-59 DEXAMETHASONE SODIUM PHOSPHATE WEST-WARD PHARMS INT Labeling Approval
06/05/2024 PREDNISONE
ANDA #084283		 SUPPL-47 PREDNISONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084610		 SUPPL-42 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084611		 SUPPL-46 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084612		 SUPPL-33 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084613		 SUPPL-43 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084754		 SUPPL-61 DEXAMETHASONE ANIMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084763		 SUPPL-28 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084764		 SUPPL-34 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084765		 SUPPL-30 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #084766		 SUPPL-32 DEXAMETHASONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084916		 SUPPL-75 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
06/05/2024 PREDNISONE
ANDA #085161		 SUPPL-97 PREDNISONE WATSON LABS Labeling Approval
06/05/2024 PREDNISONE
ANDA #085162		 SUPPL-85 PREDNISONE WATSON LABS Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #085456		 SUPPL-23 DEXAMETHASONE CHARTWELL RX Labeling Approval
06/05/2024 PREDNISONE
ANDA #086596		 SUPPL-24 PREDNISONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 PREDNISONE
ANDA #087342		 SUPPL-48 PREDNISONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087668		 SUPPL-26 DEXAMETHASONE SODIUM PHOSPHATE WATSON LABS Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087702		 SUPPL-50 DEXAMETHASONE SODIUM PHOSPHATE WEST-WARD PHARMS INT Labeling Approval
06/05/2024 PREDNISONE
ANDA #087800		 SUPPL-44 PREDNISONE HIKMA Labeling Approval
06/05/2024 PREDNISONE
ANDA #087801		 SUPPL-37 PREDNISONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #087916		 SUPPL-30 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #088248		 SUPPL-27 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE INTENSOL
ANDA #088252		 SUPPL-36 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #088254		 SUPPL-21 DEXAMETHASONE PHARMOBEDIENT CNSLTG Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #088306		 SUPPL-30 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #088316		 SUPPL-26 DEXAMETHASONE HIKMA Labeling Approval
06/05/2024 PREDNISONE
ANDA #088465		 SUPPL-9 PREDNISONE HIKMA PHARMS Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #088481		 SUPPL-32 DEXAMETHASONE ALVOGEN Labeling Approval
06/05/2024 PREDNISONE
ANDA #088703		 SUPPL-32 PREDNISONE HIKMA Labeling Approval
06/05/2024 PREDNISONE INTENSOL
ANDA #088810		 SUPPL-30 PREDNISONE HIKMA Labeling Approval
06/05/2024 PREDNISONE
ANDA #088832		 SUPPL-46 PREDNISONE MYLAN Labeling Approval
06/05/2024 PRELONE
ANDA #089081		 SUPPL-40 PREDNISOLONE TEVA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #089169		 SUPPL-21 DEXAMETHASONE SODIUM PHOSPHATE DR REDDYS Labeling Approval
06/05/2024 PREDNISONE
ANDA #089247		 SUPPL-39 PREDNISONE SUN PHARM INDUSTRIES Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #090891		 SUPPL-3 DEXAMETHASONE LYNE Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #091188		 SUPPL-7 DEXAMETHASONE CHARTWELL MOLECULAR Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #091396		 SUPPL-5 PREDNISOLONE SODIUM PHOSPHATE MISSION PHARMA Labeling Approval
06/05/2024 RAYOS
NDA #202020		 SUPPL-13 PREDNISONE HORIZON Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #203129		 SUPPL-9 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #203559		 SUPPL-6 PREDNISOLONE SODIUM PHOSPHATE EDENBRIDGE PHARMS Labeling Approval
06/05/2024 UCERIS
NDA #203634		 SUPPL-12 BUDESONIDE SALIX Labeling Approval
06/05/2024 PREDNISOLONE SODIUM PHOSPHATE
ANDA #204962		 SUPPL-2 PREDNISOLONE SODIUM PHOSPHATE PHARM ASSOC Labeling Approval
06/05/2024 PREGABALIN
ANDA #205321		 SUPPL-1 PREGABALIN AUROBINDO PHARMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #206781		 SUPPL-8 DEXAMETHASONE SODIUM PHOSPHATE EUGIA PHARMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #207442		 SUPPL-16 DEXAMETHASONE SODIUM PHOSPHATE SOMERSET THERAPS LLC Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #207521		 SUPPL-3 DEXAMETHASONE SODIUM PHOSPHATE SOMERSET Labeling Approval
06/05/2024 PREDNISONE
ANDA #208412		 SUPPL-7 PREDNISONE STRIDES PHARMA Labeling Approval
06/05/2024 GALAFOLD
NDA #208623		 SUPPL-8 MIGALASTAT HYDROCHLORIDE AMICUS THERAP US Labeling Approval
06/05/2024 EMFLAZA
NDA #208684		 SUPPL-6 DEFLAZACORT PTC THERAP Labeling Approval
06/05/2024 EMFLAZA
NDA #208685		 SUPPL-7 DEFLAZACORT PTC THERAP Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #208689		 SUPPL-7 DEXAMETHASONE SODIUM PHOSPHATE AMNEAL Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #208690		 SUPPL-9 DEXAMETHASONE SODIUM PHOSPHATE AMNEAL Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #209192		 SUPPL-4 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
06/05/2024 PREDNISONE
ANDA #209727		 SUPPL-5 PREDNISONE STRIDES PHARMA Labeling Approval
06/05/2024 MAYZENT
NDA #209884		 SUPPL-19 SIPONIMOD NOVARTIS Labeling Approval
06/05/2024 ZEPOSIA
NDA #209899		 SUPPL-13 OZANIMOD HYDROCHLORIDE BRISTOL Labeling Approval
06/05/2024 ZEPOSIA
NDA #209899		 SUPPL-14 OZANIMOD HYDROCHLORIDE BRISTOL Labeling Approval
06/05/2024 CALQUENCE
NDA #210259		 SUPPL-10 ACALABRUTINIB ASTRAZENECA Labeling Approval
06/05/2024 CANAGLIFLOZIN; METFORMIN
ANDA #210311		 ORIG-1 CANAGLIFLOZIN;METFORMIN HYDROCLORIDE INDOCO REMEDIES Tentative Approval
06/05/2024 PREDNISONE
ANDA #210525		 SUPPL-6 PREDNISONE GENEYORK PHARMS Labeling Approval
06/05/2024 PREDNISONE
ANDA #210785		 SUPPL-5 PREDNISONE STRIDES PHARMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #210966		 SUPPL-5 DEXAMETHASONE SODIUM PHOSPHATE EUGIA PHARMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #210967		 SUPPL-5 DEXAMETHASONE SODIUM PHOSPHATE EUGIA PHARMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #211036		 SUPPL-7 DEXAMETHASONE SODIUM PHOSPHATE SOMERSET THERAPS LLC Labeling Approval
06/05/2024 HEMADY
NDA #211379		 SUPPL-6 DEXAMETHASONE DEXCEL Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #211451		 SUPPL-2 DEXAMETHASONE SODIUM PHOSPHATE HIKMA Labeling Approval
06/05/2024 PREDNISONE
ANDA #211496		 SUPPL-4 PREDNISONE GENEYORK PHARMS Labeling Approval
06/05/2024 PREDNISONE
ANDA #211575		 SUPPL-16 PREDNISONE NOVITIUM PHARMA Labeling Approval
06/05/2024 ORTIKOS
NDA #211929		 SUPPL-11 BUDESONIDE SUN PHARM INDS INC Labeling Approval
06/05/2024 PREDNISONE
ANDA #213385		 SUPPL-4 PREDNISONE AMNEAL Labeling Approval
06/05/2024 PREDNISONE
ANDA #213386		 SUPPL-4 PREDNISONE AMNEAL Labeling Approval
06/05/2024 PONVORY
NDA #213498		 SUPPL-5 PONESIMOD JANSSEN PHARMS Labeling Approval
06/05/2024 PONVORY
NDA #213498		 SUPPL-6 PONESIMOD JANSSEN PHARMS Labeling Approval
06/05/2024 ALKINDI SPRINKLE
NDA #213876		 SUPPL-5 HYDROCORTISONE ETON Labeling Approval
06/05/2024 LAMOTRIGINE
ANDA #213949		 SUPPL-1 LAMOTRIGINE YILING Labeling Approval
06/05/2024 SUMATRIPTAN
ANDA #214209		 SUPPL-2 SUMATRIPTAN CIPLA Manufacturing (CMC) Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #214890		 SUPPL-1 DEXAMETHASONE SODIUM PHOSPHATE GENEYORK PHARMS Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #214891		 SUPPL-1 DEXAMETHASONE SODIUM PHOSPHATE GENEYORK PHARMS Labeling Approval
06/05/2024 TASCENSO ODT
NDA #214962		 SUPPL-2 FINGOLIMOD LAURYL SULFATE CYCLE Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #215106		 SUPPL-2 DEXAMETHASONE AMNEAL Labeling Approval
06/05/2024 AGAMREE
NDA #215239		 SUPPL-1 VAMOROLONE CATALYST PHARMS Labeling Approval
06/05/2024 PREDNISONE
ANDA #215246		 SUPPL-8 PREDNISONE NOVITIUM PHARMA Labeling Approval
06/05/2024 PALBOCICLIB
ANDA #215570		 ORIG-1 PALBOCICLIB SYNTHON PHARMS INC Approval
06/05/2024 DEXAMETHASONE
ANDA #215604		 SUPPL-6 DEXAMETHASONE NOVITIUM PHARMA Labeling Approval
06/05/2024 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #215654		 SUPPL-3 DEXAMETHASONE SODIUM PHOSPHATE GLAND PHARMA LTD Labeling Approval
06/05/2024 PREDNISONE
ANDA #215671		 SUPPL-1 PREDNISONE AUROBINDO PHARMA LTD Labeling Approval
06/05/2024 PREDNISONE
ANDA #215672		 SUPPL-1 PREDNISONE AUROBINDO PHARMA LTD Labeling Approval
06/05/2024 PREDNISOLONE
ANDA #215673		 SUPPL-1 PREDNISOLONE AUROBINDO PHARMA LTD Labeling Approval
06/05/2024 TARPEYO
NDA #215935		 SUPPL-4 BUDESONIDE CALLIDITAS Labeling Approval
06/05/2024 TARPEYO
NDA #215935		 SUPPL-5 BUDESONIDE CALLIDITAS Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #216295		 SUPPL-1 DEXAMETHASONE AMNEAL Labeling Approval
06/05/2024 CALQUENCE
NDA #216387		 SUPPL-4 ACALABRUTINIB MALEATE ASTRAZENECA Labeling Approval
06/05/2024 AZELASTINE HYDROCHLORIDE
ANDA #216576		 ORIG-1 AZELASTINE HYDROCHLORIDE AMNEAL Approval
06/05/2024 VELSIPITY
NDA #216956		 SUPPL-1 ETRASIMOD ARGININE PFIZER Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #217001		 SUPPL-2 DEXAMETHASONE BIONPHARMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #217538		 SUPPL-1 DEXAMETHASONE BIONPHARMA Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #217695		 SUPPL-1 DEXAMETHASONE APOTEX Labeling Approval
06/05/2024 DEXAMETHASONE
ANDA #217696		 SUPPL-6 DEXAMETHASONE NOVITIUM PHARMA Labeling Approval
06/06/2024 METHAMPHETAMINE HYDROCHLORIDE
ANDA #091189		 SUPPL-8 METHAMPHETAMINE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
06/06/2024 ZOLEDRONIC ACID
ANDA #201783		 SUPPL-24 ZOLEDRONIC ACID AVET LIFESCIENCES Labeling Approval
06/06/2024 MYCOPHENOLATE MOFETIL
ANDA #204076		 SUPPL-5 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM Manufacturing (CMC) Approval
06/06/2024 MYCOPHENOLATE MOFETIL
ANDA #204076		 SUPPL-6 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM Labeling Approval
06/06/2024 MYCOPHENOLATE MOFETIL
ANDA #204077		 SUPPL-5 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM Labeling Approval
06/06/2024 MYCOPHENOLATE MOFETIL
ANDA #204077		 SUPPL-6 MYCOPHENOLATE MOFETIL ZHEJIANG HISUN PHARM Labeling Approval
06/06/2024 PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
ANDA #204559		 SUPPL-16 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE STRIDES PHARMA Labeling Approval
06/06/2024 PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
ANDA #204559		 SUPPL-19 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE STRIDES PHARMA Labeling Approval
06/06/2024 LEQVIO
NDA #214012		 SUPPL-11 INCLISIRAN SODIUM NOVARTIS Labeling Approval
06/06/2024 VENLAFAXINE HYDROCHLORIDE
ANDA #217767		 ORIG-1 VENLAFAXINE HYDROCHLORIDE ALEMBIC Approval
06/06/2024 RYTELO
NDA #217779		 ORIG-1 IMETELSTAT GERON CORP Type 1 - New Molecular Entity Approval
06/07/2024 MIRAPEX ER
NDA #022421		 SUPPL-23 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/07/2024 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #050671		 SUPPL-32 VANCOMYCIN HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
06/07/2024 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-40 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
06/07/2024 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-41 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
06/07/2024 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-42 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
06/07/2024 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-43 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
06/07/2024 LORAZEPAM
ANDA #076150		 SUPPL-6 LORAZEPAM INTL MEDICATION SYS Labeling Approval
06/07/2024 CARBOPLATIN
ANDA #076517		 SUPPL-24 CARBOPLATIN HOSPIRA Labeling Approval
06/07/2024 CARBOPLATIN
ANDA #077059		 SUPPL-24 CARBOPLATIN HOSPIRA Labeling Approval
06/07/2024 PREDNISONE
ANDA #080514		 SUPPL-12 PREDNISONE CHARTWELL MOLECULAR Labeling Approval
06/07/2024 PREDNISONE
ANDA #080514		 SUPPL-13 PREDNISONE CHARTWELL MOLECULAR Labeling Approval
06/07/2024 PREDNISONE
ANDA #084275		 SUPPL-11 PREDNISONE CHARTWELL MOLECULAR Labeling Approval
06/07/2024 PREDNISONE
ANDA #084275		 SUPPL-12 PREDNISONE CHARTWELL MOLECULAR Labeling Approval
06/07/2024 KEYTRUDA
BLA #125514		 SUPPL-154 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/07/2024 DEXAMETHASONE
ANDA #201270		 SUPPL-4 DEXAMETHASONE LARKEN LABS INC Labeling Approval
06/07/2024 LENVIMA
NDA #206947		 SUPPL-31 LENVATINIB MESYLATE EISAI INC Efficacy Approval
06/07/2024 LEVORPHANOL TARTRATE
ANDA #212024		 SUPPL-6 LEVORPHANOL TARTRATE SPECGX LLC Labeling Approval
06/07/2024 PREDNISONE
ANDA #212629		 SUPPL-1 PREDNISONE GRANULATION TECH Labeling Approval
06/07/2024 KLISYRI
NDA #213189		 SUPPL-1 TIRBANIBULIN ALMIRALL Labeling Approval
06/07/2024 KLISYRI
NDA #213189		 SUPPL-3 TIRBANIBULIN ALMIRALL Labeling Approval
06/07/2024 KLISYRI
NDA #213189		 SUPPL-5 TIRBANIBULIN ALMIRALL Efficacy Approval
06/07/2024 LEVORPHANOL TARTRATE
ANDA #213906		 SUPPL-5 LEVORPHANOL TARTRATE SUN PHARM INDS INC Labeling Approval
06/07/2024 NASONEX 24HR ALLERGY
NDA #215712		 SUPPL-17 MOMETASONE FUROATE PERRIGO PHARMA INTL Manufacturing (CMC) Approval
06/07/2024 MOTPOLY XR
NDA #216185		 SUPPL-1 LACOSAMIDE AUCTA Efficacy Approval
06/07/2024 FLUPHENAZINE HYDROCHLORIDE
ANDA #218283		 ORIG-1 FLUPHENAZINE HYDROCHLORIDE RISING Approval
06/07/2024 ACETYLCYSTEINE
ANDA #218397		 ORIG-1 ACETYLCYSTEINE SOMERSET THERAPS LLC Approval
06/10/2024 CIMETIDINE HYDROCHLORIDE
ANDA #074251		 SUPPL-5 CIMETIDINE HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
06/10/2024 KARIVA
ANDA #075863		 SUPPL-35 DESOGESTREL; ETHINYL ESTRADIOL BARR Labeling Approval
06/10/2024 KARIVA
ANDA #075863		 SUPPL-37 DESOGESTREL; ETHINYL ESTRADIOL BARR Labeling Approval
06/10/2024 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #076916		 SUPPL-14 DESOGESTREL; ETHINYL ESTRADIOL DR REDDYS LABS SA Labeling Approval
06/10/2024 AUBAGIO
NDA #202992		 SUPPL-17 TERIFLUNOMIDE SANOFI AVENTIS US Labeling Approval
06/10/2024 TRETINOIN
ANDA #208279		 SUPPL-4 TRETINOIN GLENMARK PHARMS LTD Labeling Approval
06/10/2024 ITRACONAZOLE
ANDA #208591		 SUPPL-10 ITRACONAZOLE ALKEM LABS LTD Labeling Approval
06/10/2024 EPHEDRINE SULFATE
NDA #208609		 SUPPL-12 EPHEDRINE SULFATE RENEW PHARMS Labeling Approval
06/10/2024 EZETIMIBE AND SIMVASTATIN
ANDA #208699		 SUPPL-4 EZETIMIBE; SIMVASTATIN GLENMARK PHARMS LTD Labeling Approval
06/10/2024 EZETIMIBE AND SIMVASTATIN
ANDA #208699		 SUPPL-5 EZETIMIBE; SIMVASTATIN GLENMARK PHARMS LTD Labeling Approval
06/10/2024 CLOBAZAM
ANDA #209795		 SUPPL-5 CLOBAZAM HETERO LABS LTD III Labeling Approval
06/10/2024 CLOBAZAM
ANDA #209808		 SUPPL-3 CLOBAZAM PIRAMAL HLTHCARE UK Labeling Approval
06/10/2024 PAROXETINE HYDROCHLORIDE
ANDA #213485		 SUPPL-1 PAROXETINE HYDROCHLORIDE CSPC OUYI Labeling Approval
06/10/2024 ZINC SULFATE
ANDA #218059		 ORIG-1 ZINC SULFATE APOTEX Approval
06/10/2024 IQIRVO
NDA #218860		 ORIG-1 ELAFIBRANOR IPSEN BIOPHARM LTD Type 1 - New Molecular Entity Approval
06/10/2024 KEVZARA
BLA #761037		 SUPPL-15 SARILUMAB SANOFI SYNTHELABO Approval
06/11/2024 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #206006		 SUPPL-8 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE RISING Labeling Approval
06/11/2024 PITAVASTATIN CALCIUM
ANDA #206015		 SUPPL-8 PITAVASTATIN CALCIUM AUROBINDO PHARMA Labeling Approval
06/11/2024 PITAVASTATIN CALCIUM
ANDA #206047		 SUPPL-2 PITAVASTATIN CALCIUM ZYDUS PHARMS Labeling Approval
06/11/2024 HYDROCORTISONE
ANDA #207029		 SUPPL-5 HYDROCORTISONE STRIDES PHARMA Labeling Approval
06/11/2024 HYDROCORTISONE
ANDA #207029		 SUPPL-17 HYDROCORTISONE STRIDES PHARMA Labeling Approval
06/11/2024 POMALIDOMIDE
ANDA #210164		 ORIG-1 POMALIDOMIDE APOTEX Approval
06/11/2024 VALGANCICLOVIR HYDROCHLORIDE
ANDA #212876		 ORIG-1 VALGANCICLOVIR HYDROCHLORIDE GPP Approval
06/11/2024 HYDROCORTISONE
ANDA #214649		 SUPPL-1 HYDROCORTISONE AUROBINDO PHARMA LTD Labeling Approval
06/11/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #218092		 ORIG-1 ESOMEPRAZOLE MAGNESIUM GLENMARK SPECLT Approval
06/11/2024 TRANEXAMIC ACID
ANDA #218320		 ORIG-1 TRANEXAMIC ACID RUBICON Approval
06/12/2024 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020201		 SUPPL-45 DOBUTAMINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/12/2024 AMOXICILLIN
ANDA #065322		 SUPPL-35 AMOXICILLIN HIKMA Labeling Approval
06/12/2024 AMOXICILLIN
ANDA #065322		 SUPPL-38 AMOXICILLIN HIKMA Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE
ANDA #074137		 SUPPL-16 BUPRENORPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE
ANDA #074137		 SUPPL-28 BUPRENORPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE
ANDA #074137		 SUPPL-36 BUPRENORPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE
ANDA #074137		 SUPPL-40 BUPRENORPHINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/12/2024 CLONAZEPAM
ANDA #074869		 SUPPL-37 CLONAZEPAM ACTAVIS ELIZABETH Labeling Approval
06/12/2024 CLONAZEPAM
ANDA #074869		 SUPPL-38 CLONAZEPAM ACTAVIS ELIZABETH Labeling Approval
06/12/2024 CLONAZEPAM
ANDA #074869		 SUPPL-42 CLONAZEPAM ACTAVIS ELIZABETH Labeling Approval
06/12/2024 CLONAZEPAM
ANDA #074869		 SUPPL-43 CLONAZEPAM ACTAVIS ELIZABETH Labeling Approval
06/12/2024 FLUOXETINE HYDROCHLORIDE
ANDA #075577		 SUPPL-14 FLUOXETINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
06/12/2024 FLUOXETINE HYDROCHLORIDE
ANDA #075577		 SUPPL-15 FLUOXETINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
06/12/2024 OXYBUTYNIN CHLORIDE
ANDA #076745		 SUPPL-21 OXYBUTYNIN CHLORIDE IMPAX PHARMS Labeling Approval
06/12/2024 OXYBUTYNIN CHLORIDE
ANDA #076745		 SUPPL-24 OXYBUTYNIN CHLORIDE IMPAX PHARMS Labeling Approval
06/12/2024 RISPERIDONE
ANDA #076908		 SUPPL-1 RISPERIDONE CHARTWELL RX Labeling Approval
06/12/2024 RISPERIDONE
ANDA #076908		 SUPPL-2 RISPERIDONE CHARTWELL RX Labeling Approval
06/12/2024 RISPERIDONE
ANDA #076908		 SUPPL-3 RISPERIDONE CHARTWELL RX Labeling Approval
06/12/2024 RISPERIDONE
ANDA #076908		 SUPPL-4 RISPERIDONE CHARTWELL RX Labeling Approval
06/12/2024 PAROXETINE HYDROCHLORIDE
ANDA #077584		 SUPPL-37 PAROXETINE HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
06/12/2024 RISPERIDONE
ANDA #079088		 SUPPL-17 RISPERIDONE TORRENT PHARMS Labeling Approval
06/12/2024 RISPERIDONE
ANDA #079088		 SUPPL-18 RISPERIDONE TORRENT PHARMS Labeling Approval
06/12/2024 RISPERIDONE
ANDA #079088		 SUPPL-20 RISPERIDONE TORRENT PHARMS Labeling Approval
06/12/2024 RISPERIDONE
ANDA #079088		 SUPPL-21 RISPERIDONE TORRENT PHARMS Labeling Approval
06/12/2024 RISPERIDONE
ANDA #079088		 SUPPL-22 RISPERIDONE TORRENT PHARMS Labeling Approval
06/12/2024 RISPERIDONE
ANDA #079088		 SUPPL-24 RISPERIDONE TORRENT PHARMS Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-3 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-7 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-8 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-9 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-10 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-11 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RIFAMPIN
ANDA #091181		 SUPPL-12 RIFAMPIN FRESENIUS KABI USA Labeling Approval
06/12/2024 RISPERIDONE
ANDA #201003		 SUPPL-19 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
06/12/2024 RISPERIDONE
ANDA #201003		 SUPPL-28 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
06/12/2024 RISPERIDONE
ANDA #201003		 SUPPL-45 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
06/12/2024 FARXIGA
NDA #202293		 SUPPL-31 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
06/12/2024 POLYMYXIN B SULFATE
ANDA #202766		 SUPPL-6 POLYMYXIN B SULFATE XELLIA PHARMS APS Labeling Approval
06/12/2024 LANSOPRAZOLE
ANDA #203083		 SUPPL-3 LANSOPRAZOLE HETERO LABS LTD III Labeling Approval
06/12/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 SUPPL-8 ESOMEPRAZOLE MAGNESIUM TORRENT Labeling Approval
06/12/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 SUPPL-11 ESOMEPRAZOLE MAGNESIUM TORRENT Labeling Approval
06/12/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 SUPPL-15 ESOMEPRAZOLE MAGNESIUM TORRENT Labeling Approval
06/12/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 SUPPL-16 ESOMEPRAZOLE MAGNESIUM TORRENT Labeling Approval
06/12/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 SUPPL-18 ESOMEPRAZOLE MAGNESIUM TORRENT Labeling Approval
06/12/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #203636		 SUPPL-20 ESOMEPRAZOLE MAGNESIUM TORRENT Labeling Approval
06/12/2024 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
ANDA #204558		 SUPPL-5 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA Labeling Approval
06/12/2024 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
ANDA #204558		 SUPPL-7 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA Labeling Approval
06/12/2024 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
ANDA #204558		 SUPPL-10 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA Labeling Approval
06/12/2024 ACYCLOVIR
ANDA #205470		 ORIG-1 ACYCLOVIR TARO Approval
06/12/2024 XIGDUO XR
NDA #205649		 SUPPL-22 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Efficacy Approval
06/12/2024 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #206006		 SUPPL-9 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE RISING Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-10 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-18 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-23 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #211785		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #211785		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #211785		 SUPPL-8 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #211785		 SUPPL-13 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES Labeling Approval
06/12/2024 RETEVMO
NDA #213246		 SUPPL-9 SELPERCATINIB LOXO ONCOL ELI LILLY Efficacy Approval
06/12/2024 LEVORPHANOL TARTRATE
ANDA #213479		 SUPPL-20 LEVORPHANOL TARTRATE NOVITIUM PHARMA Labeling Approval
06/12/2024 EPOPROSTENOL SODIUM
ANDA #213913		 ORIG-1 EPOPROSTENOL SODIUM MYLAN Approval
06/12/2024 BRIMONIDINE TARTRATE
ANDA #216772		 ORIG-1 BRIMONIDINE TARTRATE UPSHER SMITH LABS Approval
06/12/2024 POSACONAZOLE
ANDA #217553		 SUPPL-1 POSACONAZOLE GLAND PHARMA LTD Labeling Approval
06/12/2024 GUANFACINE HYDROCHLORIDE
ANDA #217638		 ORIG-1 GUANFACINE HYDROCHLORIDE WANBANG BIOPHARMS Approval
06/12/2024 RETEVMO
NDA #218160		 SUPPL-1 SELPERCATINIB LOXO ONCOL ELI LILLY Efficacy Approval
06/12/2024 NAPROXEN
ANDA #218497		 ORIG-1 NAPROXEN NOVITIUM PHARMA Approval
06/12/2024 HYRIMOZ
BLA #761071		 SUPPL-21 ADALIMUMAB-ADAZ SANDOZ INC Approval
06/12/2024 ADBRY
BLA #761180		 SUPPL-6 TRALOKINUMAB LEO PHARMA AS Approval
06/13/2024 POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-25 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/13/2024 POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-25 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/13/2024 POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-25 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/13/2024 POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-25 POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
06/13/2024 RAPIVAB
NDA #206426		 SUPPL-9 PERAMIVIR BIOCRYST Labeling Approval
06/13/2024 AUGTYRO
NDA #218213		 SUPPL-1 REPOTRECTINIB BRISTOL Efficacy Approval
06/14/2024 BLINCYTO
BLA #125557		 SUPPL-28 BLINATUMOMAB AMGEN Approval
06/14/2024 IMFINZI
BLA #761069		 SUPPL-45 DURVALUMAB ASTRAZENECA UK LTD Approval
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