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ROSIGLITAZONE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN PHARMA · Approved 2008-12-02

Drug application

FDA Application #

ANDA078825

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROSIGLITAZONE MALEATE

Generic name

Rosiglitazone Maleate

Active ingredients

ROSIGLITAZONE MALEATE

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

MYLAN PHARMA

First approval

2008-12-02

Source

Authoritative

Drugs@FDA application overview

Machine

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