Benztropine Mesylate
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg
Approved
Approval ID
4f03e640-f945-4bbe-8a66-b13b3996ed57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2011
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-776
Application NumberANDA040742
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2011
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT