APPLICATION
NDA019090
TYPE
NDA
ORIGINAL APPROVAL
1984-10-19
LATEST ACTION
2009-09-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ZANTAC · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-03-14Manufacturing (CMC) · Supplement 47 · standardAP
2002-01-15Manufacturing (CMC) · Supplement 46 · standardAP
2001-11-06Manufacturing (CMC) · Supplement 41 · standardAP
2001-05-09Labeling · Supplement 44 · standardAP
1999-10-29Labeling · Supplement 43 · standardAP
1999-10-22Labeling · Supplement 40 · standardAP
1999-10-22Labeling · Supplement 39 · standardAP
1999-04-02Manufacturing (CMC) · Supplement 42 · standardAP
1998-01-14Manufacturing (CMC) · Supplement 38 · standardAP
1994-11-03Labeling · Supplement 35 · standardAP
1993-04-05Labeling · Supplement 32AP
1992-07-22Manufacturing (CMC) · Supplement 31 · standardAP
1992-05-19Manufacturing (CMC) · Supplement 28 · standardAP
1991-11-25Labeling · Supplement 24AP
1991-09-05Labeling · Supplement 30AP
1990-12-20Manufacturing (CMC) · Supplement 29 · standardAP
1990-12-12Manufacturing (CMC) · Supplement 26 · standardAP
1990-11-21Labeling · Supplement 27AP
1990-09-26Manufacturing (CMC) · Supplement 18 · standardAP
1990-08-13Efficacy · Supplement 17AP
1990-07-16Labeling · Supplement 25AP
1990-06-25Manufacturing (CMC) · Supplement 21 · standardAP
1989-08-08Manufacturing (CMC) · Supplement 19 · standardAP
1989-05-18Labeling · Supplement 20AP
1989-03-17Labeling · Supplement 16AP
1989-03-17Labeling · Supplement 13AP
1988-05-20Labeling · Supplement 14AP
1988-05-20Labeling · Supplement 15AP
1988-05-19Labeling · Supplement 12AP
1988-03-03Manufacturing (CMC) · Supplement 8 · standardAP
1987-11-24Manufacturing (CMC) · Supplement 11 · standardAP
1987-04-09Manufacturing (CMC) · Supplement 4 · standardAP
1987-04-09Labeling · Supplement 9AP
1987-04-09Manufacturing (CMC) · Supplement 5 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 6 · 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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