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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
Cipla USA Inc.
DUNS: 078719707
Effective Date
May 1, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Benzatropine(1 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Cipla USA Inc.

078719707

Manufacturing Establishments1

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

InvaGen Pharmaceutical Inc

Cipla USA Inc.

Cipla USA Inc.

080334903

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
69097-827
Application Number
ANDA090294
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2018
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

Benztropine Mesylate

Product Details

NDC Product Code
69097-826
Application Number
ANDA090294
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2018
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: WMJ8TL7510Class: ACTIBQuantity: 0.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Benztropine Mesylate

Product Details

NDC Product Code
69097-832
Application Number
ANDA090294
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2018
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
Code: WMJ8TL7510Class: ACTIBQuantity: 2 mg in 1 1
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