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FDA Approval

Benztropine Mesylate

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

September 28, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Benzatropine(0.5 mg in 1 1)

Registrants (1)

Bryant Ranch Prepack

DUNS Number

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Labeler

Bryant Ranch Prepack

Registrant

Bryant Ranch Prepack

DUNS Number

171714327

Products (1)

Benztropine Mesylate

NDC Product Code

72162-1155

Application Number

ANDA204713

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 27, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

BenzatropineActive

Code: WMJ8TL7510Class: ACTIBQuantity: 0.5 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

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