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FLUVASTATIN SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAR PHARM · Approved 2009-09-15

Drug application

FDA Application #

ANDA078872

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUVASTATIN SODIUM

Generic name

Fluvastatin Sodium

Active ingredients

FLUVASTATIN SODIUM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

PAR PHARM

First approval

2009-09-15

Source

Authoritative

Drugs@FDA application overview

Machine

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