MedPath
FDA Approval

Alfuzosin Hydrochloride

November 26, 2019

HUMAN PRESCRIPTION DRUG LABEL

Alfuzosin(10 mg in 1 1)

Registrants (1)

Wockhardt Limited

650069115

Manufacturing Establishments (1)

Wockhardt Limited

Wockhardt USA LLC.

Wockhardt Limited

676257570

Products (1)

Alfuzosin Hydrochloride

64679-738

ANDA090221

ANDA (C73584)

ORAL

November 26, 2019

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
HYDROXYPROPYL CELLULOSE (TYPE M)Inactive
Code: U3JF91U133Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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