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FDA ANDA · ANDA078170

METFORMIN HYDROCHLORIDE

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA078170
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-23
LATEST ACTION
2012-12-11
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

2012-12-11Labeling · Supplement 5AP
2010-05-20Labeling · Supplement 6AP
2010-02-25Labeling · Supplement 14AP
2010-01-27Labeling · Supplement 15AP
2008-05-23OriginalAP
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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