APPLICATION
ANDA076706
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-14
LATEST ACTION
2019-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-03-01Labeling · Supplement 16 · standardAP
2019-03-01Labeling · Supplement 14 · standardAP
2009-12-30Labeling · Supplement 13AP
2008-02-11Labeling · Supplement 8AP
2006-11-07Labeling · Supplement 6AP
2005-12-29Labeling · Supplement 1AP
2004-12-14OriginalAP
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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