ANDA 90713, held by Teva Pharms USA. Palonosetron Hydrochloride.
As of Nov 13, 2026, ANDA 90713 (Palonosetron Hydrochloride), held by Teva Pharms USA, was first approved by FDA on Mar 23, 2018, with 1 approved supplement and 0 published complete response letters.
Palonosetron hydrochloride injection is indicated in adults for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Palonosetron HydrochlorideEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) · injectable;intravenous | Palonosetron Hydrochloride | Rx |
| Palonosetron HydrochlorideEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) · injectable;intravenous | Palonosetron Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 23, 2018 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
