Ondansetron

Prevents nausea and vomiting. ANDA 90469, held by Aurobindo Pharma. Ondansetron.

As of Nov 14, 2026, ANDA 90469 (Ondansetron), held by Aurobindo Pharma, was first approved by FDA on Apr 12, 2010, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2010
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 12, 2010	Original application	Approved	None posted

Products

2 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Nov 24, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Jan 31, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Jan 31, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Mar 7, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Mar 27, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Mar 27, 2017	Supplement 11Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Feb 16, 2012	Supplement 3Labeling	Approved	None posted
Dec 8, 2010	Supplement 1Labeling	Approved	None posted
Apr 12, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90469
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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