← FDA Drug Approvals (Drugs@FDA)

ROSIGLITAZONE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA PHARMS · Approved 2009-12-08

Drug application

FDA Application #

ANDA078658

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

HIKMA PHARMS

First approval

2009-12-08

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown