Application 019048
- Type
- NDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESOWEN | DESONIDE | CREAM;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0299-5770 | DesOwen | desonide | Galderma Laboratories, L.P. | NDA | Current |
| 0472-0804 | Desonide | desonide | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 63187-747 | Desonide | Desonide | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 63187-747 | Desonide | Desonide | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 63187-747 | Desonide | Desonide | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 69007-770 | desonide | desonide | Owen Laboratories, Inc. | NDA AUTHORIZED GENERIC | Current |