Drug application
OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
Drugs@FDA NDA 202799 · TAKEDA PHARMS USA
Key facts
| Drug name | OMONTYS PRESERVATIVE FREE |
|---|---|
| Active ingredients | PEGINESATIDE ACETATE |
| Application type | NDA |
| Application number | 202799 |
| Company | TAKEDA PHARMS USA |
| Dosage forms | SOLUTION, INTRAVENOUS, SUBCUTANEOUS |
| Strength | EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Mar 27, 2012 |
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: