Fluvastatin Sodium
These highlights do not include all the information needed to use FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS. FLUVASTATIN SODIUM extended-release tablets, for oral useInitial U.S. Approval: 2000
Approved
Approval ID
cc55110f-1ad6-4f97-840d-62b3a5ac415a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2020
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.
Fluvastatin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7446
Application NumberANDA079011
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvastatin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2022
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)Inactive
Code: M825OX60H9
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FLUVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT