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FDA Approval

Alfuzosin Hydrochloride

CompanyGolden State Medical Supply, Inc. (DUNS: 603184490)

Effective Date

October 9, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Alfuzosin(10 mg in 1 1)

Manufacturing Establishments (1)

Golden State Medical Supply, Inc.

Labeler

Golden State Medical Supply, Inc.

DUNS Number

603184490

Products (1)

Alfuzosin Hydrochloride

NDC Product Code

51407-829

Application Number

ANDA079013

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 9, 2023

Ingredients

HYPROMELLOSE 2208 (4000 MPA.S)Inactive

Code: 39J80LT57TClass: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ACETATE PHTHALATEInactive

Code: 58QVG85GW3Class: IACT

AlfuzosinActive

Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

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