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
69097-827Application Number
ANDA090294Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 11, 2018SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
BenzatropineActive
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
69097-826Application Number
ANDA090294Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 11, 2018SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
BenzatropineActive
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
69097-832Application Number
ANDA090294Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 11, 2018SILICON 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
BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 2 mg in 1 1