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SIMVASTATIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2007-05-11

Drug application

FDA Application #

ANDA078103

Application type

Abbreviated New Drug Application (Generic)

Brand name

SIMVASTATIN

Generic name

SIMVASTATIN

Active ingredients

SIMVASTATIN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2007-05-11

Source

Authoritative

Drugs@FDA application overview

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