Application 214902
- Type
- NDA
- Sponsor
- SOL-GEL TECHNOLOGIES LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TWYNEO | TRETINOIN;BENZOYL PEROXIDE | CREAM;TOPICAL | 0.1%;3% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0299-5945 | TWYNEO | tretinoin and benzoyl peroxide | Galderma Laboratories, L.P. | NDA | Current |
| 79167-301 | TWYNEO | tretinoin and benzoyl peroxide | Sol-Gel Technologies, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71605 | ORIG | 2022-07-20 |
| 68198 | ORIG | 2021-07-27 |
| 68197 | ORIG | 2021-07-27 |