APPLICATION
ANDA075973
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-25
LATEST ACTION
2024-06-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
Approval history
2024-06-04Manufacturing (CMC) · Supplement 36 · unknownAP
2019-01-14Labeling · Supplement 20 · standardAP
2019-01-14Labeling · Supplement 19 · standardAP
2014-06-17Labeling · Supplement 11AP
2012-02-09Manufacturing (CMC) · Supplement 15AP
2008-02-29Labeling · Supplement 9AP
2007-06-13Labeling · Supplement 8AP
2005-05-11Labeling · Supplement 5AP
2002-10-11Labeling · Supplement 2AP
2002-04-11Labeling · Supplement 1AP
2002-01-25OriginalAP
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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