Drug application
POSFREA (PALONOSETRON HYDROCHLORIDE)
Drugs@FDA NDA 203050 · AVYXA HOLDINGS
Key facts
| Drug name | POSFREA |
|---|---|
| Active ingredients | PALONOSETRON HYDROCHLORIDE |
| Application type | NDA |
| Application number | 203050 |
| Company | AVYXA HOLDINGS |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Mar 1, 2016 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: