APPLICATION
NDA017939
TYPE
NDA
ORIGINAL APPROVAL
1977-08-16
LATEST ACTION
1997-04-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TAGAMETDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1997-04-15Manufacturing (CMC) · Supplement 86 · priorityAP
1995-02-22Labeling · Supplement 85 · priorityAP
1993-11-10Manufacturing (CMC) · Supplement 84 · priorityAP
1993-06-08Manufacturing (CMC) · Supplement 83 · priorityAP
1992-08-27Manufacturing (CMC) · Supplement 79 · priorityAP
1992-07-16Manufacturing (CMC) · Supplement 81 · priorityAP
1992-01-07Labeling · Supplement 80 · priorityAP
1991-11-13Efficacy · Supplement 77 · priorityAP
1991-03-07Labeling · Supplement 73 · priorityAP
1990-05-30Manufacturing (CMC) · Supplement 74 · priorityAP
1990-03-21Manufacturing (CMC) · Supplement 76 · priorityAP
1989-11-13Efficacy · Supplement 66 · priorityAP
1989-06-26Labeling · Supplement 72 · priorityAP
1989-06-26Labeling · Supplement 70 · priorityAP
1989-03-20Manufacturing (CMC) · Supplement 71 · priorityAP
1988-06-15Labeling · Supplement 68 · priorityAP
1988-05-20Labeling · Supplement 67 · priorityAP
1988-03-31Efficacy · Supplement 64 · priorityAP
1987-06-03Manufacturing (CMC) · Supplement 65 · priorityAP
1986-07-24Manufacturing (CMC) · Supplement 63 · priorityAP
1986-04-29Efficacy · Supplement 55 · priorityAP
1986-04-23Labeling · Supplement 61 · priorityAP
1986-01-13Labeling · Supplement 59 · priorityAP
1985-11-20Efficacy · Supplement 39 · priorityAP
1985-05-15Labeling · Supplement 58 · priorityAP
1985-04-18Labeling · Supplement 57 · priorityAP
1985-02-07Labeling · Supplement 56 · priorityAP
1985-01-23Manufacturing (CMC) · Supplement 54 · priorityAP
1984-07-19Labeling · Supplement 45 · priorityAP
1984-07-19Labeling · Supplement 52 · priorityAP
1984-07-11Manufacturing (CMC) · Supplement 51 · priorityAP
1984-06-18Labeling · Supplement 53 · priorityAP
1984-03-05Labeling · Supplement 50 · priorityAP
1984-03-05Labeling · Supplement 49 · priorityAP
1984-02-28Manufacturing (CMC) · Supplement 44 · priorityAP
1983-11-29Labeling · Supplement 47 · priorityAP
1983-04-22Manufacturing (CMC) · Supplement 40 · priorityAP
1983-02-28Labeling · Supplement 42 · priorityAP
1983-01-31Efficacy · Supplement 41 · priorityAP
1982-12-30Efficacy · Supplement 26 · 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.