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FDA ANDA · ANDA078658

ROSIGLITAZONE MALEATE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA078658
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

ROSIGLITAZONE MALEATENone (Tentative Approval)
ROSIGLITAZONE MALEATE 8MG · TABLET · ORAL
ROSIGLITAZONE MALEATENone (Tentative Approval)
ROSIGLITAZONE MALEATE 2MG · TABLET · ORAL
ROSIGLITAZONE MALEATENone (Tentative Approval)
ROSIGLITAZONE MALEATE 4MG · TABLET · ORAL

Approval history

2009-12-08OriginalTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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