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FDA ANDA · ANDA202917

METFORMIN HYDROCHLORIDE

Sponsor: SUN PHARM

APPLICATION
ANDA202917
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-01
LATEST ACTION
2024-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-09-27Labeling · Supplement 14 · standardAP
2024-01-03Labeling · Supplement 1 · standardAP
2024-01-03Labeling · Supplement 6 · standardAP
2019-07-22Manufacturing (CMC) · Supplement 7AP
2016-08-01UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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