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FDA ANDA · ANDA077853

METFORMIN HYDROCHLORIDE

Sponsor: PROVIDENT PHARM

APPLICATION
ANDA077853
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-28
LATEST ACTION
2007-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2007-05-25Labeling · Supplement 2AP
2006-07-28OriginalAP
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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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