Benztropine Mesylate
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg
Approved
Approval ID
c06c51ff-65ba-42c1-9dd8-e8d4a212981b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2011
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 2
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 Code64725-2434
Application NumberANDA040742
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (6)
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
benztropine mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-2435
Application NumberANDA040715
Product Classification
M
Marketing Category
C73584
G
Generic Name
benztropine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (6)
BENZTROPINE MESYLATEActive
Quantity: 2 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT