Application 201923
- Type
- NDA
- Sponsor
- ALIMERA SCIENCES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ILUVIEN | FLUOCINOLONE ACETONIDE | IMPLANT;INTRAVITREAL | 0.19MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68611-190 | Iluvien | fluocinolone acetonide | Alimera Sciences, Inc. | NDA | Current |
| 68611-190 | Iluvien | fluocinolone acetonide | Alimera Sciences, Inc. | NDA | Current |
| 68611-190 | Iluvien | fluocinolone acetonide | Alimera Sciences, Inc. | NDA | Current |
| 68611-190 | Iluvien | fluocinolone acetonide | Alimera Sciences, Inc. | NDA | Current |
| 68611-190 | Iluvien | fluocinolone acetonide | Alimera Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81582 | SUPPL | 2025-03-17 |
| 81562 | SUPPL | 2025-03-14 |
| 47563 | SUPPL | 2017-03-14 |
| 47514 | SUPPL | 2017-03-09 |
| 22865 | ORIG | 2016-03-18 |
| 40093 | ORIG | 2014-09-30 |
| 32148 | ORIG | 2014-09-29 |