← FDA DRUG APPROVALS
FDA NDA · NDA019434
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: GLAXOSMITHKLINE
APPLICATION
NDA019434
TYPE
NDA
ORIGINAL APPROVAL
1985-10-31
LATEST ACTION
1998-01-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1998-01-08Manufacturing (CMC) · Supplement 30 · standardAP
1997-04-15Manufacturing (CMC) · Supplement 29 · standardAP
1996-10-23Manufacturing (CMC) · Supplement 22 · standardAP
1995-02-22Labeling · Supplement 27 · standardAP
1994-12-06Manufacturing (CMC) · Supplement 28 · standardAP
1993-11-10Manufacturing (CMC) · Supplement 26 · standardAP
1993-09-13Manufacturing (CMC) · Supplement 25 · standardAP
1993-06-08Manufacturing (CMC) · Supplement 24 · standardAP
1992-08-27Manufacturing (CMC) · Supplement 18 · standardAP
1992-07-16Manufacturing (CMC) · Supplement 20 · standardAP
1992-06-04Manufacturing (CMC) · Supplement 21 · standardAP
1992-01-30Manufacturing (CMC) · Supplement 16 · standardAP
1992-01-07Labeling · Supplement 19 · standardAP
1991-11-13Labeling · Supplement 14 · standardAP
1991-05-23Manufacturing (CMC) · Supplement 15 · standardAP
1991-03-07Labeling · Supplement 10 · standardAP
1990-05-30Manufacturing (CMC) · Supplement 11 · standardAP
1989-11-13Labeling · Supplement 13 · standardAP
1989-06-26Labeling · Supplement 9 · standardAP
1989-06-26Labeling · Supplement 7 · standardAP
1989-03-20Manufacturing (CMC) · Supplement 8 · standardAP
1988-06-15Labeling · Supplement 5 · standardAP
1988-05-20Labeling · Supplement 4 · standardAP
1988-03-31Efficacy · Supplement 3 · standardAP
1986-04-29Labeling · Supplement 2 · standardAP
1986-04-23Labeling · Supplement 1 · standardAP
1985-10-31Type 3 - New Dosage Form · Original · standardAP
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.
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