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FDA ANDA · ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
metformin hydrochloride
Sponsor: MARKSANS PHARMA
APPLICATION
ANDA090295
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-29
LATEST ACTION
2021-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-06-25Labeling · Supplement 2 · standardAP
2021-06-25Labeling · Supplement 3 · standardAP
2016-04-29OriginalAP
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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