← FDA DRUG APPROVALS

FDA ANDA · ANDA076864

METFORMIN HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA076864
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-12
LATEST ACTION
2019-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-03-01Labeling · Supplement 15 · standardAP
2019-03-01Labeling · Supplement 16 · standardAP
2011-12-13Labeling · Supplement 6AP
2010-10-22Labeling · Supplement 11AP
2010-04-27Labeling · Supplement 9AP
2007-04-18Labeling · Supplement 4AP
2007-01-03Labeling · Supplement 3AP
2005-04-12OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →