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FDA Approval

Benztropine Mesylate

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

FDA Approval Summary

Company
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Effective Date
May 21, 2014
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.

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products2

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

Benztropine Mesylate

Product Details

NDC Product Code
43353-796
Application Number
ANDA040742
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 21, 2014
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Benztropine Mesylate

Product Details

NDC Product Code
43353-913
Application Number
ANDA040738
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 21, 2014
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 0.5 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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