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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
Major Pharmaceuticals
DUNS: 191427277
Effective Date
December 3, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Benzatropine(0.5 mg in 1 1)

Products3

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
0904-6788
Application Number
ANDA204713
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 8, 2019
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: WMJ8TL7510Class: ACTIBQuantity: 0.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Benztropine Mesylate

Product Details

NDC Product Code
0904-6790
Application Number
ANDA204713
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 8, 2019
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Benztropine Mesylate

Product Details

NDC Product Code
0904-6789
Application Number
ANDA204713
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 8, 2019
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: WMJ8TL7510Class: ACTIBQuantity: 2 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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