Ondansetron

Prevents nausea and vomiting. ANDA 78152, held by Glenmark Pharms Ltd. Ondansetron.

As of Nov 15, 2026, ANDA 78152 (Ondansetron), held by Glenmark Pharms Ltd, was first approved by FDA on Jun 27, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2007
Supplements approved: 10
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. Ondansetron is 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 11 submissions below

Date	Submission	Status	Documents
Jun 27, 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 11 submissions, including labeling and manufacturing supplements


Sep 9, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Feb 13, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Mar 30, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Dec 8, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Dec 8, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Sep 30, 2011	Supplement 5Labeling	Approved	None posted
Sep 30, 2011	Supplement 4Labeling	Approved	None posted
Jul 25, 2011	Supplement 3Labeling	Approved	None posted
Oct 23, 2008	Supplement 2Labeling	Approved	None posted
Aug 18, 2008	Supplement 1Labeling	Approved	None posted
Jun 27, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78152
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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