BENZTROPINE MESYLATE
BENZTROPINE MESYLATE TABLETS USP0.5 mg, 1 mg and 2 mgRx only
Approved
Approval ID
ecb65310-e54e-48f8-a61b-4177bac41252
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-286
Application NumberANDA072266
Product Classification
M
Marketing Category
C73584
G
Generic Name
BENZTROPINE MESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2010
FDA Product Classification
INGREDIENTS (5)
BENZTROPINE MESYLATEActive
Quantity: 2 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT