Application 091306
- Type
- ANDA
- Sponsor
- IDENTI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | OIL/DROPS;OTIC | 0.01% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-283 | Fluocinolone Acetonide | Fluocinolone Acetonide | AvKARE, Inc. | ANDA | Current |
| 65162-702 | Fluocinolone Acetonide | Fluocinolone Acetonide | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-702 | Fluocinolone Acetonide | Fluocinolone Acetonide | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-702 | Fluocinolone Acetonide | Fluocinolone Acetonide | Amneal Pharmaceuticals, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43248 | ORIG | 2011-12-02 |