Axid

NDA 19508, held by Smithkline Beecham. Nizatidine.

As of Nov 14, 2026, NDA 19508 (Axid), held by Smithkline Beecham, was first approved by FDA on Apr 12, 1988, with 27 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1988
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Sep 21, 1993	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 26, 1991	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 12, 1988	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Axid150MG · capsule;oral	Nizatidine	Discontinued
Axid300MG · capsule;oral	Nizatidine	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Jan 24, 2006	Supplement 34Manufacturing · Standard review	Approved	Letter
Dec 23, 2005	Supplement 33Manufacturing · Standard review	Approved	Letter Label
Mar 2, 2001	Supplement 30Labeling · Standard review	Approved	Letter
Jan 19, 1999	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 13, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 19, 1998	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 8, 1996	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 23, 1996	Supplement 23Manufacturing · Standard review	Approved	None posted
May 22, 1996	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 6, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 31, 1995	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 2, 1995	Supplement 22Labeling · Standard review	Approved	None posted
Sep 21, 1993	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
May 13, 1993	Supplement 19Manufacturing · Standard review	Approved	None posted
May 13, 1993	Supplement 18Labeling · Standard review	Approved	None posted
Jun 9, 1992	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 25, 1991	Supplement 17Labeling · Standard review	Approved	None posted
Nov 25, 1991	Supplement 15Labeling · Standard review	Approved	None posted
Jul 26, 1991	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 11, 1991	Supplement 14Labeling · Standard review	Approved	None posted
Aug 29, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 29, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 10, 1990	Supplement 13Labeling · Standard review	Approved	None posted
Apr 21, 1989	Supplement 6Labeling · Standard review	Approved	None posted
Mar 16, 1989	Supplement 4Labeling · Standard review	Approved	None posted
Feb 23, 1989	Supplement 3Labeling · Standard review	Approved	None posted
Jun 20, 1988	Supplement 1Labeling · Standard review	Approved	None posted
Apr 12, 1988	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19508
Drugs@FDA: Overview at FDA
Company: SmithKline Beecham

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters