Fluvastatin Sodium
These highlights do not include all the information needed to use FLUVASTATIN CAPSULES safely and effectively. See full prescribing information for FLUVASTATIN CAPSULES. FLUVASTATIN capsules for oral useInitial U.S. Approval: 1993
Approved
Approval ID
d0a7247c-5d83-4bc1-840f-c58314d14195
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2020
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-8020
Application NumberANDA090595
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluvastatin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2020
FDA Product Classification
INGREDIENTS (14)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FLUVASTATIN SODIUMActive
Quantity: 20 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
fluvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-8021
Application NumberANDA090595
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluvastatin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2020
FDA Product Classification
INGREDIENTS (14)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FLUVASTATIN SODIUMActive
Quantity: 40 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT