Nizatidine

ANDA 75461, held by Ani Pharms. Nizatidine.

As of Nov 15, 2026, ANDA 75461 (Nizatidine), held by Ani Pharms, was first approved by FDA on Jul 8, 2002, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 8, 2002
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
Jul 8, 2002	Original application	Approved	None posted

Products

2 strengths and forms


Nizatidine150MG · capsule;oral	Nizatidine	Discontinued
Nizatidine300MG · capsule;oral	Nizatidine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 14, 2006	Supplement 10Labeling	Approved	None posted
Jul 8, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75461
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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