Axid

NDA 21494, held by Braintree. Nizatidine.

As of Nov 14, 2026, NDA 21494 (Axid), held by Braintree, was first approved by FDA on May 25, 2004, with 1 approved supplement and 0 published complete response letters.

First approved: May 25, 2004
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 25, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Axid15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Nizatidine	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Mar 21, 2005	Supplement 1Manufacturing · Standard review	Approved	Letter Label
May 25, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21494
Drugs@FDA: Overview at FDA
Company: Braintree Laboratories, Inc.

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