← FDA DRUG APPROVALS

FDA ANDA · ANDA075985

METFORMIN HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA075985
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-25
LATEST ACTION
2010-06-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL

Approval history

2010-06-21Labeling · Supplement 37AP
2009-08-20Labeling · Supplement 35AP
2008-10-09Labeling · Supplement 34AP
2008-05-12Labeling · Supplement 26AP
2008-01-28Labeling · Supplement 30AP
2005-01-27Labeling · Supplement 14AP
2002-08-29Manufacturing (CMC) · Supplement 4AP
2002-08-29Manufacturing (CMC) · Supplement 5AP
2002-08-29Manufacturing (CMC) · Supplement 3AP
2002-08-13Labeling · Supplement 9AP
2002-06-12Manufacturing (CMC) · Supplement 2AP
2002-06-12Manufacturing (CMC) · Supplement 1AP
2002-04-11Labeling · Supplement 8AP
2002-01-25OriginalAP
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 →