APPLICATION
NDA018703
TYPE
NDA
ORIGINAL APPROVAL
1983-06-09
LATEST ACTION
2009-09-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZANTAC 300 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZANTAC 150 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-01-15Manufacturing (CMC) · Supplement 62 · standardAP
2001-05-09Labeling · Supplement 60 · standardAP
1999-10-29Labeling · Supplement 59 · standardAP
1999-10-22Labeling · Supplement 57 · standardAP
1999-10-22Labeling · Supplement 58 · standardAP
1996-11-27Labeling · Supplement 55 · standardAP
1996-01-26Manufacturing (CMC) · Supplement 52 · standardAP
1995-03-29Efficacy · Supplement 50 · standardAP
1994-11-03Efficacy · Supplement 47AP
1994-11-03Labeling · Supplement 53 · standardAP
1994-10-19Manufacturing (CMC) · Supplement 51 · standardAP
1994-02-28Efficacy · Supplement 46AP
1993-06-03Manufacturing (CMC) · Supplement 49 · standardAP
1993-04-05Labeling · Supplement 48AP
1992-07-22Manufacturing (CMC) · Supplement 45 · standardAP
1992-07-02Manufacturing (CMC) · Supplement 44 · standardAP
1992-05-19Efficacy · Supplement 42AP
1991-11-25Labeling · Supplement 36AP
1991-01-04Manufacturing (CMC) · Supplement 34 · standardAP
1991-01-04Manufacturing (CMC) · Supplement 35 · standardAP
1990-12-20Manufacturing (CMC) · Supplement 41 · standardAP
1990-12-12Manufacturing (CMC) · Supplement 39 · standardAP
1990-11-21Labeling · Supplement 40AP
1990-07-16Labeling · Supplement 37AP
1990-02-06Manufacturing (CMC) · Supplement 32 · standardAP
1989-08-08Manufacturing (CMC) · Supplement 31 · standardAP
1989-05-18Labeling · Supplement 33AP
1989-02-03Labeling · Supplement 29AP
1988-10-25Labeling · Supplement 30AP
1988-09-30Manufacturing (CMC) · Supplement 27 · standardAP
1988-09-29Manufacturing (CMC) · Supplement 28 · standardAP
1988-05-20Labeling · Supplement 26AP
1988-05-20Labeling · Supplement 25AP
1987-10-29Labeling · Supplement 24AP
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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