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FDA Approval

Benztropine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Contract Pharmacy Services-PA
DUNS: 945429777
Effective Date
December 19, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Benzatropine(1 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Coupler Enteprises Inc.

Contract Pharmacy Services-PA

945429777

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benztropine

Product Details

NDC Product Code
67046-207
Application Number
ANDA090168
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 19, 2018
Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1
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