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FDA ANDA · ANDA075984

METFORMIN HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA075984
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-23
LATEST ACTION
2015-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL

Approval history

2015-08-20Labeling · Supplement 20AP
2007-11-13Labeling · Supplement 13AP
2005-01-27Labeling · Supplement 8AP
2004-11-01Labeling · Supplement 5AP
2004-02-18Labeling · Supplement 2AP
2002-04-23OriginalAP
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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