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FDA ANDA · ANDA077337

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA077337
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-07
LATEST ACTION
2017-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM, ROSIGLITAZONE MALEATE EQ 4MG BASE · TABLET · ORAL
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG, ROSIGLITAZONE MALEATE EQ 4MG BASE · TABLET · ORAL
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG, ROSIGLITAZONE MALEATE EQ 1MG BASE · TABLET · ORAL
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM, ROSIGLITAZONE MALEATE EQ 2MG BASE · TABLET · ORAL
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG, ROSIGLITAZONE MALEATE EQ 2MG BASE · TABLET · ORAL

Approval history

2017-05-19Original — Label ↗AP
2017-04-05Labeling · Supplement 1 · standard — Letter ↗AP
2014-05-07Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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