Ondansetron

ANDA 78139, held by Pharmobedient. Ondansetron.

As of Nov 14, 2026, ANDA 78139 (Ondansetron), held by Pharmobedient, was first approved by FDA on Jun 25, 2007, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 25, 2007
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 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 7 submissions, including labeling and manufacturing supplements


Jan 31, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Jan 31, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Mar 7, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Mar 31, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Dec 7, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Aug 27, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Jun 25, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78139
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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