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FDA Approval

Alfuzosin Hydrochloride

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

April 5, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Alfuzosin(10 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Alfuzosin Hydrochloride

NDC Product Code

54868-6329

Application Number

ANDA079013

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 27, 2012

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSE 2208 (4000 MPA.S)Inactive

Code: 39J80LT57TClass: IACT

AlfuzosinActive

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

POLYVINYL ACETATE PHTHALATEInactive

Code: 58QVG85GW3Class: IACT

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