Application 075860
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESONIDE | DESONIDE | LOTION;TOPICAL | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0310 | desonide | desonide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0310 | desonide | desonide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0462-0392 | LoKara | desonide | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8813 | ORIG | 2003-04-10 |