NDA 208109, held by Fresenius Kabi USA. Palonosetron Hydrochloride.
As of Nov 13, 2026, NDA 208109 (Palonosetron Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Nov 21, 2017, with 1 approved supplement and 0 published complete response letters.
| Dec 6, 2018 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Palonosetron HydrochlorideEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) · solution;intravenous | Palonosetron Hydrochloride | DiscontinuedReference drug |
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
