Drug application
PALONOSETRON HYDROCHLORIDE (PALONOSETRON HYDROCHLORIDE)
Drugs@FDA ANDA 207364 · SOMERSET THERAPS LLC
Key facts
| Drug name | PALONOSETRON HYDROCHLORIDE |
|---|---|
| Active ingredients | PALONOSETRON HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 207364 |
| Company | SOMERSET THERAPS LLC |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 0.25MG(BASE)/5ML(0.05MG(BASE)/ML |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Sep 1, 2017 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None 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: