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ROSIGLITAZONE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ROXANE · Approved 2008-03-10

Drug application

FDA Application #

ANDA078695

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

ROXANE

First approval

2008-03-10

Source

Authoritative

Drugs@FDA application overview

Machine

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