APPLICATION
NDA017924
TYPE
NDA
ORIGINAL APPROVAL
1977-08-16
LATEST ACTION
1997-04-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
TAGAMETDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
1997-04-15Manufacturing (CMC) · Supplement 59 · priorityAP
1995-02-22Labeling · Supplement 58 · priorityAP
1993-11-10Manufacturing (CMC) · Supplement 57 · priorityAP
1993-06-08Manufacturing (CMC) · Supplement 56 · priorityAP
1992-08-27Manufacturing (CMC) · Supplement 52 · priorityAP
1992-07-16Manufacturing (CMC) · Supplement 54 · priorityAP
1992-01-07Labeling · Supplement 53 · priorityAP
1991-11-13Labeling · Supplement 50 · priorityAP
1991-03-07Labeling · Supplement 46 · priorityAP
1990-05-30Manufacturing (CMC) · Supplement 47 · priorityAP
1989-11-13Labeling · Supplement 49 · priorityAP
1989-06-26Labeling · Supplement 44 · priorityAP
1989-06-26Labeling · Supplement 45 · priorityAP
1988-06-15Labeling · Supplement 42 · priorityAP
1988-05-20Labeling · Supplement 41 · priorityAP
1988-03-31Efficacy · Supplement 40 · priorityAP
1986-04-29Efficacy · Supplement 33 · priorityAP
1986-04-23Labeling · Supplement 38 · priorityAP
1986-01-13Labeling · Supplement 37 · priorityAP
1985-05-15Labeling · Supplement 36 · priorityAP
1985-04-18Labeling · Supplement 35 · priorityAP
1985-02-07Labeling · Supplement 34 · priorityAP
1984-12-05Manufacturing (CMC) · Supplement 30 · priorityAP
1984-07-19Labeling · Supplement 27 · priorityAP
1984-07-19Labeling · Supplement 31 · priorityAP
1984-06-14Labeling · Supplement 32 · priorityAP
1984-03-05Labeling · Supplement 29 · priorityAP
1983-03-11Manufacturing (CMC) · Supplement 23 · priorityAP
1983-02-28Labeling · Supplement 25 · priorityAP
1983-01-31Efficacy · Supplement 24 · priorityAP
1982-12-30Efficacy · Supplement 11 · priorityAP
1982-12-30Labeling · Supplement 18 · priorityAP
1982-08-25Efficacy · Supplement 22 · priorityAP
1982-01-22Labeling · Supplement 19 · priorityAP
1981-11-02Labeling · Supplement 17 · priorityAP
1981-07-13Labeling · Supplement 16 · priorityAP
1981-06-12Manufacturing (CMC) · Supplement 14 · priorityAP
1981-01-22Labeling · Supplement 13 · priorityAP
1981-01-22Labeling · Supplement 12 · priorityAP
1980-07-08Labeling · Supplement 10 · priorityAP
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.