Clemastine Fumarate
CLEMASTINE FUMARATE TABLETS, USP Rx only
Approved
Approval ID
14aaadca-7d86-47e8-8483-6e05d456949d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clemastine Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-0308
Application NumberANDA073283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clemastine Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLEMASTINE FUMARATEActive
Quantity: 2.68 mg in 1 1
Code: 19259EGQ3D
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT