APPLICATION
ANDA076869
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-12
LATEST ACTION
2019-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-02-26Labeling · Supplement 26 · standardAP
2019-02-26Labeling · Supplement 24 · standardAP
2008-10-31Labeling · Supplement 11AP
2007-05-25Labeling · Supplement 4AP
2005-04-12OriginalAP
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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