APPLICATION
ANDA076650
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-13
LATEST ACTION
2019-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-11-14Labeling · Supplement 8 · standardAP
2019-11-14Labeling · Supplement 7 · standardAP
2010-09-29Labeling · Supplement 5AP
2007-03-09Labeling · Supplement 3AP
2005-09-13OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.