Drug application
KALYDECO (IVACAFTOR)
Drugs@FDA NDA 207925 · VERTEX PHARMS INC
Key facts
| Drug name | KALYDECO |
|---|---|
| Active ingredients | IVACAFTOR |
| Application type | NDA |
| Application number | 207925 |
| Company | VERTEX PHARMS INC |
| Dosage forms | GRANULE, ORAL |
| Strength | 50MG/PACKET |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Mar 17, 2015 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 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: