Ondansetron Hydrochloride Preservative Free, Ondansetron

ANDA 79032, held by Am Regent. Ondansetron Hydrochloride, Ondansetron.

As of Nov 15, 2026, ANDA 79032 (Ondansetron Hydrochloride Preservative Free, Ondansetron), held by Am Regent, was first approved by FDA on Nov 18, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 18, 2008
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
Nov 18, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Ondansetron Hydrochloride Preservative FreeEQ 2MG BASE/ML · injectable;injection	Ondansetron Hydrochloride	Discontinued
Ondansetron4MG/2ML · injectable; injection	Ondansetron	Rx

All 3 submissions, including labeling and manufacturing supplements


Jan 15, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jan 4, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Nov 18, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 79032
Drugs@FDA: Overview at FDA
Company: Am Regent

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