← FDA DRUG APPROVALS

FDA ANDA · ANDA065171

DEMECLOCYCLINE HYDROCHLORIDE

Sponsor: BARR

APPLICATION
ANDA065171
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-13
LATEST ACTION
2013-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DEMECLOCYCLINE HYDROCHLORIDEDiscontinued
DEMECLOCYCLINE HYDROCHLORIDE 300MG · TABLET · ORAL
DEMECLOCYCLINE HYDROCHLORIDEDiscontinued
DEMECLOCYCLINE HYDROCHLORIDE 150MG · TABLET · ORAL

Approval history

2013-01-31Labeling · Supplement 4 · standardAP
2012-12-11Labeling · Supplement 3AP
2004-12-13OriginalAP
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 →