APPLICATION
ANDA075285
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-29
LATEST ACTION
2020-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
CIMETIDINEOver-the-counter
CIMETIDINE 200MG · TABLET · ORAL
Approval history
2020-02-21Labeling · Supplement 44 · standardAP
2009-02-27Labeling · Supplement 30AP
2003-01-22Labeling · Supplement 8AP
2001-11-05Labeling · Supplement 6AP
2001-06-11Labeling · Supplement 5AP
1999-06-10Labeling · Supplement 3AP
1999-04-13Labeling · Supplement 2AP
1999-01-25Labeling · Supplement 1AP
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.