Prevents nausea and vomiting. ANDA 91483, held by Amneal Pharms. Ondansetron Hydrochloride.
As of Nov 15, 2026, ANDA 91483 (Ondansetron Hydrochloride), held by Amneal Pharms, was first approved by FDA on Jan 31, 2011, with 7 approved supplements and 0 published complete response letters.
Ondansetron oral solution 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 oral solution is also indicated for the prevention of postoperative nausea and/or vomiting.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ondansetron HydrochlorideEQ 4MG BASE/5ML · solution;oral | Ondansetron Hydrochloride | Rx |
| Sep 15, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jun 14, 2022 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 1, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 7, 2018 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 7, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 7, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 27, 2012 | Supplement 2Labeling | Approved | None posted |
| Jan 31, 2011 | Original application | Approved | None posted |
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
