Drug application
OTREXUP (METHOTREXATE)
Drugs@FDA NDA 204824 · COSETTE
Key facts
| Drug name | OTREXUP |
|---|---|
| Active ingredients | METHOTREXATE |
| Application type | NDA |
| Application number | 204824 |
| Company | COSETTE |
| Dosage forms | SOLUTION, SUBCUTANEOUS |
| Strength | 10MG/0.4ML (10MG/0.4ML) |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Efficacy |
| Latest submission status date | Oct 11, 2013 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 10–99 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: