APPLICATION
ANDA077336
TYPE
ANDA
ORIGINAL APPROVAL
2006-02-09
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 15 · standardAP
2019-03-01Labeling · Supplement 12 · standardAP
2015-09-28Labeling · Supplement 7 · standardAP
2010-11-19Labeling · Supplement 4AP
2007-11-07Labeling · Supplement 1AP
2006-02-09OriginalAP
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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