Ondansetron

Prevents nausea and vomiting. ANDA 77557, held by Sun Pharm Inds. Ondansetron.

As of Nov 15, 2026, ANDA 77557 (Ondansetron), held by Sun Pharm Inds, was first approved by FDA on Aug 2, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2007
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ondansetron is 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetronis a 5-HT 3 receptor antagonist 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 2, 2007	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 10 submissions, including labeling and manufacturing supplements


Nov 9, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Nov 9, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Mar 14, 2018	Supplement 15Labeling · Standard review	Approved	None posted
Mar 24, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Mar 24, 2017	Supplement 14Labeling · Standard review	Approved	None posted
Feb 28, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Oct 7, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Apr 26, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Jun 18, 2008	Supplement 2Labeling	Approved	None posted
Aug 2, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77557
Drugs@FDA: Overview at FDA
Company: Sun 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