Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rimantadine Hydrochloride
Product Details
NDC Product Code
68151-2103Application Number
ANDA076132Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 17, 2010MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
RimantadineActive
Code: JEI07OOS8YClass: ACTIBQuantity: 100 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT