Ondansetron

ANDA 78602, held by Sun Pharm Inds Ltd. Ondansetron.

As of Nov 15, 2026, ANDA 78602 (Ondansetron), held by Sun Pharm Inds Ltd, was first approved by FDA on Feb 24, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2011
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 24, 2011	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 10 submissions, including labeling and manufacturing supplements


Nov 24, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Jun 26, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jun 26, 2024	Supplement 8Labeling · Standard review	Approved	None posted
May 14, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Mar 27, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Mar 27, 2017	Supplement 5Labeling · Standard review	Approved	None posted
Jan 15, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jan 15, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Oct 17, 2011	Supplement 1Labeling	Approved	None posted
Feb 24, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78602
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