Drug application
PALONOSETRON HYDROCHLORIDE (PALONOSETRON HYDROCHLORIDE)
Drugs@FDA ANDA 090713 · TEVA PHARMS USA
Key facts
| Drug name | PALONOSETRON HYDROCHLORIDE |
|---|---|
| Active ingredients | PALONOSETRON HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 090713 |
| Company | TEVA PHARMS USA |
| Dosage forms | INJECTABLE, INTRAVENOUS |
| Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Mar 23, 2018 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 10–99 Therapeutic equivalents
- Yes FDA letters on file
- No 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: