MedPath
FDA Approval

Benzphetamine Hydrochloride

December 27, 2023

HUMAN PRESCRIPTION DRUG LABEL

Benzphetamine(50 mg in 1 1)

Registrants (1)

Epic Pharma, LLC

827915443

Manufacturing Establishments (1)

Epic Pharma, LLC

Epic Pharma, LLC

Epic Pharma, LLC

827915443

Products (1)

Benzphetamine Hydrochloride

42806-081

ANDA090346

ANDA (C73584)

ORAL

December 27, 2023

Code: 43DWT87QT7Class: ACTIBQuantity: 50 mg in 1 1
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL 800Inactive
Code: UH6KR4953DClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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