APPLICATION
ANDA075969
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
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 11 · standardAP
2019-11-14Labeling · Supplement 12 · standardAP
2007-06-08Labeling · Supplement 9AP
2004-06-18Labeling · Supplement 5AP
2003-01-02Labeling · Supplement 2AP
2002-11-06Manufacturing (CMC) · Supplement 1AP
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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