APPLICATION
ANDA075967
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2019-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
Approval history
2019-11-04Labeling · Supplement 38 · standardAP
2019-11-04Labeling · Supplement 37 · standardAP
2008-09-30Labeling · Supplement 25AP
2007-09-04Labeling · Supplement 20AP
2007-07-11Labeling · Supplement 23AP
2007-04-17Labeling · Supplement 17AP
2006-07-07Labeling · Supplement 15AP
2005-02-14Labeling · Supplement 10AP
2002-12-16Manufacturing (CMC) · Supplement 4AP
2002-12-16Labeling · Supplement 5AP
2002-11-01Manufacturing (CMC) · Supplement 6AP
2002-08-23Labeling · Supplement 3AP
2002-08-23Manufacturing (CMC) · Supplement 1AP
2002-08-23Manufacturing (CMC) · Supplement 2AP
2002-01-29OriginalAP
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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