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FDA Approval

Oxybutynin Chloride

CompanyTeva Pharmaceuticals USA, Inc. (DUNS: 001627975)

Effective Date

September 30, 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxybutynin(5 mg in 1 1)

Products (1)

Oxybutynin Chloride

NDC Product Code

50111-456

Application Number

ANDA071655

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2015

Ingredients

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

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