Drug application
RUZURGI (AMIFAMPRIDINE)
Drugs@FDA NDA 209321 · JACOBUS PHARM CO INC
Key facts
| Drug name | RUZURGI |
|---|---|
| Active ingredients | AMIFAMPRIDINE |
| Application type | NDA |
| Application number | 209321 |
| Company | JACOBUS PHARM CO INC |
| Dosage forms | TABLET, ORAL |
| Strength | 10MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | Yes |
| Latest submission class | Efficacy |
| Latest submission status date | May 6, 2019 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 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: