Skip to contentApplication 213189
- Type
- NDA
- Sponsor
- ATHENEX INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KLISYRI | TIRBANIBULIN | OINTMENT;TOPICAL | 1% | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16110-391 | Klisyri | tirbanibulin | Almirall, LLC | NDA | Current |
| 16110-391 | Klisyri | tirbanibulin | Almirall, LLC | NDA | Current |
| 16110-391 | Klisyri | tirbanibulin | Almirall, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78759 | SUPPL | 2024-07-02 |
| 78758 | SUPPL | 2024-07-02 |
| 78757 | SUPPL | 2024-07-02 |
| 78775 | SUPPL | 2024-06-12 |
| 78774 | SUPPL | 2024-06-12 |
| 78773 | SUPPL | 2024-06-12 |
| 65761 | ORIG | 2020-12-28 |
| 65598 | ORIG | 2020-12-15 |
| 65590 | ORIG | 2020-12-15 |