Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
TYA Pharmaceuticals
938389038
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
TYA Pharmaceuticals
TYA Pharmaceuticals
TYA Pharmaceuticals
938389038
Products1
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
64725-0012Application Number
NDA012015Marketing Category
NDA authorized generic (C73605)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
August 10, 2012BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT