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.
Fluvastatin Sodium
Product Details
NDC Product Code
68151-1326Application Number
ANDA090595Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 25, 2013STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FluvastatinActive
Code: PYF7O1FV7FClass: ACTIMQuantity: 20 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT