Application 214510
- Type
- NDA
- Sponsor
- SOL-GEL TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPSOLAY | BENZOYL PEROXIDE | CREAM;TOPICAL | 5% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0299-5890 | EPSOLAY | Benzoyl Peroxide | Galderma Laboratories, L.P. | NDA | Current |
| 0299-5890 | EPSOLAY | Benzoyl Peroxide | Galderma Laboratories, L.P. | NDA | Current |
| 79167-005 | EPSOLAY | BENZOYL PEROXIDE | Sol-Gel Technologies Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73455 | ORIG | 2023-02-13 |
| 70815 | ORIG | 2022-04-26 |