Drug application
SCOMARA (SIROLIMUS)
Drugs@FDA NDA 218528 · AFT PHARMACEUTICALS LTD
Key facts
| Drug name | SCOMARA |
|---|---|
| Active ingredients | SIROLIMUS |
| Application type | NDA |
| Application number | 218528 |
| Company | AFT PHARMACEUTICALS LTD |
| Dosage forms | CREAM, TOPICAL |
| Strength | 0.5% sirolimus in 30g tube |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Jul 20, 2026 |
At a glance
- 1–9 Submissions
- 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: