Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Moehs Catalana S.L
Graviti Pharmaceuticals Private Limited
Graviti Pharmaceuticals Private Limited
460021629
suven life sciences
Graviti Pharmaceuticals Private Limited
Graviti Pharmaceuticals Private Limited
677604288
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amantadine hydrochloride
Product Details
NDC Product Code
69844-027Application Number
ANDA207571Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 11, 2019AmantadineActive
Code: M6Q1EO9TD0Class: ACTIBQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT