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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

FLUVASTATIN SODIUM

ANDA

Tentative Approval

FLUVASTATIN SODIUM | A078872 | PAR PHARM

API Supply Chain6 active DMFs5 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

BIOCON LTDFLUVASTATIN SODIUM AMORPHOUS

DMF 184932005

BIOCON LTDFLUVASTATIN SODIUM

DMF 187622005

FIS FABBRICA ITALIANA SINTETICI SPAFLUVASTATIN SODIUM HYDRATE USP

DMF 189112005

TAPI NL BVFLUVASTATIN SODIUM

DMF 192962006

PHARMATHEN INDUSTRIAL SAFLUVASTATIN SODIUM AMORPHOUS

DMF 240912010

BIOCON LTDFLUVASTATIN SODIUM

DMF 367352022

CADILA HEALTHCARE LTDInactiveFLUVASTATIN SODIUM

DMF 178792004

USV LTDInactiveFLUVASTATIN SODIUM USP

DMF 205282007

LUPIN LTDInactiveFLUVASTATIN SODIUM (MICRONIZED) USP

DMF 215092008

AUROBINDO PHARMA LTDInactiveFLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE)

DMF 236572010

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveFLUVASTATIN SODIUM USP

DMF 259922012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 23, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 80MG

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TABLET, EXTENDED RELEASE; ORAL | TA Date: 2009-09-15 00:00:00

No patent or exclusivity listings for this strength.