APPLICATION
NDA019508
TYPE
NDA
ORIGINAL APPROVAL
1988-04-12
LATEST ACTION
2006-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AXIDDiscontinued
NIZATIDINE 150MG · CAPSULE · ORAL
AXIDDiscontinued
NIZATIDINE 300MG · CAPSULE · ORAL
Approval history
1999-01-19Manufacturing (CMC) · Supplement 27 · standardAP
1998-10-13Manufacturing (CMC) · Supplement 25 · standardAP
1998-06-19Manufacturing (CMC) · Supplement 28 · standardAP
1996-10-08Manufacturing (CMC) · Supplement 24 · standardAP
1996-07-23Manufacturing (CMC) · Supplement 23 · standardAP
1996-05-22Manufacturing (CMC) · Supplement 26 · standardAP
1996-02-06Manufacturing (CMC) · Supplement 2 · standardAP
1995-08-31Manufacturing (CMC) · Supplement 21 · standardAP
1995-02-02Labeling · Supplement 22 · standardAP
1993-09-21Efficacy · Supplement 16 · standardAP
1993-05-13Manufacturing (CMC) · Supplement 19 · standardAP
1993-05-13Labeling · Supplement 18 · standardAP
1992-06-09Manufacturing (CMC) · Supplement 8 · standardAP
1991-11-25Labeling · Supplement 17 · standardAP
1991-11-25Labeling · Supplement 15 · standardAP
1991-07-26Efficacy · Supplement 12 · standardAP
1991-04-11Labeling · Supplement 14 · standardAP
1990-08-29Manufacturing (CMC) · Supplement 5 · standardAP
1990-08-29Manufacturing (CMC) · Supplement 10 · standardAP
1990-04-10Labeling · Supplement 13 · standardAP
1989-04-21Labeling · Supplement 6 · standardAP
1989-03-16Labeling · Supplement 4 · standardAP
1989-02-23Labeling · Supplement 3 · standardAP
1988-06-20Labeling · Supplement 1 · standardAP
1988-04-12Type 1 - New Molecular Entity · 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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