APPLICATION
ANDA206955
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-07
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-06-07Labeling · Supplement 25 · standardAP
2019-11-05Labeling · Supplement 10 · standardAP
2019-11-05Labeling · Supplement 3 · standardAP
2019-04-17Manufacturing (CMC) · Supplement 12 · standardAP
2016-12-07UNKNOWN · Original · standardAP
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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