Skip to contentApplication 213691
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMPEKLO | CLOBETASOL PROPIONATE | LOTION;TOPICAL | 0.05% W/W | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49502-537 | IMPEKLO | clobetasol propionate | Mylan Specialty L.P. | NDA | Current |
| 49502-537 | IMPEKLO | clobetasol propionate | Mylan Specialty L.P. | NDA | Current |
| 49502-537 | IMPEKLO | clobetasol propionate | Mylan Specialty L.P. | NDA | Current |
| 49502-537 | IMPEKLO | clobetasol propionate | Mylan Specialty L.P. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65145 | ORIG | 2020-11-03 |
| 63254 | ORIG | 2020-05-22 |
| 63168 | ORIG | 2020-05-20 |