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FDA Approval

Fluvastatin Sodium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Effective Date

August 20, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fluvastatin(20 mg in 1 1)

Products2

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

0378-8020

Application Number

ANDA090595

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 20, 2020

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FluvastatinActive

Code: PYF7O1FV7FClass: ACTIMQuantity: 20 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Fluvastatin Sodium

Product Details

NDC Product Code

0378-8021

Application Number

ANDA090595

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 20, 2020

Ingredients

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FluvastatinActive

Code: PYF7O1FV7FClass: ACTIMQuantity: 40 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

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