Nizatidine

ANDA 75668, held by Ani Pharms. Nizatidine.

As of Nov 15, 2026, ANDA 75668 (Nizatidine), held by Ani Pharms, was first approved by FDA on Sep 12, 2002, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 12, 2002	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jun 24, 2009	Supplement 6Labeling	Approved	None posted
May 21, 2009	Supplement 2Labeling	Approved	None posted
Sep 12, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75668
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