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FDA ANDA · ANDA076747

ROSIGLITAZONE MALEATE

Sponsor: ANI PHARMS

APPLICATION
ANDA076747
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-25
LATEST ACTION
2014-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ROSIGLITAZONE MALEATEDiscontinued
ROSIGLITAZONE MALEATE EQ 8MG BASE · TABLET · ORAL
ROSIGLITAZONE MALEATEDiscontinued
ROSIGLITAZONE MALEATE EQ 2MG BASE · TABLET · ORAL
ROSIGLITAZONE MALEATEDiscontinued
ROSIGLITAZONE MALEATE EQ 4MG BASE · TABLET · ORAL

Approval history

2014-05-07REMS · Supplement 1AP
2013-01-25Original — Label ↗AP
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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