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FDA Approval

Oxybutynin Chloride

CompanyMarlex Pharmaceuticals Inc (DUNS: 782540215)

Effective Date

October 18, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxybutynin(5 mg in 1 1)

Products (1)

Oxybutynin Chloride

NDC Product Code

10135-640

Application Number

ANDA209823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 30, 2019

Ingredients

OxybutyninActive

Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

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