← FDA DRUG APPROVALS

FDA ANDA · ANDA065425

DEMECLOCYCLINE HYDROCHLORIDE

demeclocycline

Sponsor: AMNEAL PHARM

APPLICATION
ANDA065425
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-27
LATEST ACTION
2013-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2013-02-05Labeling · Supplement 2AP
2008-02-27OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →