Application 017010
- Type
- NDA
- Sponsor
- PERRIGO NEW YORK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESONIDE | DESONIDE | CREAM;TOPICAL | 0.05% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42254-142 | Desonide | Desonide | Rebel Distributors Corp | NDA | Current |
| 45802-422 | Desonide | Desonide | Perrigo New York Inc | NDA | Current |
| 45802-422 | Desonide | Desonide | Padagis Israel Pharmaceuticals Ltd | NDA | Current |
| 45802-422 | Desonide | Desonide | Padagis Israel Pharmaceuticals Ltd | NDA | Current |
| 69482-600 | Tridesilon Cream | desonide 0.05% | Encore Dermatology Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54289 | ORIG | 2018-05-22 |