Benztropine Mesylate
Benztropine Mesylate Injection, USP
Approved
Approval ID
d61eae0d-a29d-45ef-bd41-07123e0c21f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2013
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benztropine Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0012
Application NumberNDA012015
Product Classification
M
Marketing Category
C73605
G
Generic Name
Benztropine Mesylate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateAugust 10, 2012
FDA Product Classification
INGREDIENTS (3)
Benztropine MesylateActive
Quantity: 1 mg in 1 mL
Code: WMJ8TL7510
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT