Application 208742
- Type
- NDA
- Sponsor
- OCULAR THERAPEUTIX
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXTENZA | DEXAMETHASONE | INSERT;OPHTHALMIC | 0.4MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70382-204 | DEXTENZA | dexamethasone | Ocular Therapeutix, Inc. | NDA | Current |
| 70382-204 | DEXTENZA | dexamethasone | Ocular Therapeutix, Inc. | NDA | Current |
| 70382-204 | DEXTENZA | dexamethasone | Ocular Therapeutix, Inc. | NDA | Current |
| 70382-204 | DEXTENZA | dexamethasone | Ocular Therapeutix, Inc. | NDA | Current |
| 70382-204 | DEXTENZA | dexamethasone | Ocular Therapeutix, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81908 | SUPPL | 2025-04-09 |
| 81834 | SUPPL | 2025-04-08 |
| 68963 | SUPPL | 2021-10-12 |
| 68961 | SUPPL | 2021-10-12 |
| 62023 | SUPPL | 2020-03-04 |
| 59840 | ORIG | 2019-08-26 |
| 59158 | SUPPL | 2019-06-21 |
| 59146 | SUPPL | 2019-06-21 |
| 56824 | ORIG | 2018-12-20 |