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FDA Approval

Oxybutynin Chloride

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

March 18, 2013

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxybutynin(5 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Oxybutynin Chloride

NDC Product Code

54868-2157

Application Number

ANDA071655

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 18, 2013

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

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