BENZTROPINE MESYLATE
BENZTROPINE MESYLATE Tablets USP0.5 mg, 1 mg and 2 mg
Approved
Approval ID
17277751-785c-4ce6-a47f-6bc9ea072b9b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2022
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6022
Application NumberANDA090168
Product Classification
M
Marketing Category
C73584
G
Generic Name
BENZTROPINE MESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2021
FDA Product Classification
INGREDIENTS (8)
BENZTROPINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: WMJ8TL7510
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT