APPLICATION
ANDA075976
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-24
LATEST ACTION
2019-11-14
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
2019-11-14Labeling · Supplement 21 · standardAP
2019-11-14Labeling · Supplement 20 · standardAP
2010-09-29Labeling · Supplement 17AP
2007-03-08Labeling · Supplement 14AP
2004-09-21Labeling · Supplement 8AP
2004-05-14Labeling · Supplement 7AP
2003-08-14Labeling · Supplement 4AP
2002-10-03Manufacturing (CMC) · Supplement 2AP
2002-04-11Labeling · Supplement 1AP
2002-01-24OriginalAP
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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