Application 072354
- Type
- ANDA
- Sponsor
- GALDERMA LABS LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESOWEN | DESONIDE | LOTION;TOPICAL | 0.05% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0299-5765 | DesOwen | desonide | Galderma Laboratories, L.P. | ANDA | Current |
| 0472-0803 | Desonide | desonide | Actavis Pharma, Inc. | ANDA | Current |
| 63629-8739 | Desonide | desonide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8739 | Desonide | desonide | Bryant Ranch Prepack | ANDA | Current |
| 69007-765 | desonide | desonide | Owen Laboratories, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42825 | ORIG | 2012-01-27 |