amantadine hydrochloride
Amantadine Hydrochloride Tablets, 100mg Rx only
Approved
Approval ID
e837ea34-c0cb-465a-95f8-4fcd106ce867
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2019
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amantadine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-027
Application NumberANDA207571
Product Classification
M
Marketing Category
C73584
G
Generic Name
amantadine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2019
FDA Product Classification
INGREDIENTS (7)
AMANTADINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: M6Q1EO9TD0
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT