APPLICATION
ANDA074349
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-30
LATEST ACTION
1998-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CIMETIDINEDiscontinued
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 200MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 300MG · TABLET · ORAL
Approval history
1998-03-03Manufacturing (CMC) · Supplement 1AP
1996-08-30OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.