Ondansetron

ANDA 76810, held by Teva. Ondansetron.

As of Nov 14, 2026, ANDA 76810 (Ondansetron), held by Teva, was first approved by FDA on Jun 25, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 25, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 25, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Ondansetron4MG · tablet, orally disintegrating;oral	Ondansetron	Discontinued
Ondansetron8MG · tablet, orally disintegrating;oral	Ondansetron	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 16, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Mar 16, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Feb 14, 2012	Supplement 3Labeling	Approved	None posted
Nov 30, 2010	Supplement 2Labeling	Approved	None posted
Jun 25, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 76810
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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