Application 208912
- Type
- NDA
- Sponsor
- EYEPOINT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXYCU KIT | DEXAMETHASONE | SUSPENSION;INTRAOCULAR | 9% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208912-001 | DEXYCU KIT | DEXAMETHASONE | 9% | SUSPENSION / INTRAOCULAR | RLD | 2018-02-09 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | |
| N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | |
| N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | |
| N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | |
| N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD | 2018-02-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD | 2018-02-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N208912-001 | DEXYCU KIT | 9% | SUSPENSION / INTRAOCULAR | RLD, RS | 2018-02-09 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208912-001 | 10799642 | 2032-05-11 | Drug product | 2021-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208912-001 | 10028965 | 2034-05-23 | U-2340 | 2018-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208912-001 | 10159683 | 2034-05-23 | Drug product | 2019-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208912-001 | 10022502 | 2034-06-22 | U-2340 | 2018-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208912-001 | 11097061 | 2039-06-23 | U-3418 | Drug product | 2022-09-09 | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N208912-001 | NP | 2021-02-09 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N208912-001 | NP | 2021-02-09 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N208912-001 | NP | 2021-02-09 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N208912-001 | NP | 2021-02-09 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N208912-001 | NP | 2021-02-09 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N208912-001 | NP | 2021-02-09 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N208912-001 | NP | 2021-02-09 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N208912-001 | NP | 2021-02-09 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N208912-001 | NP | 2021-02-09 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc. | 64577454-d49e-4180-99e6-8461f74b0221 | 2026-01-20 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Bryant Ranch Prepack | 075717e3-be2a-4bb3-bead-492761bfb287 | 2026-01-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Hemady | DEXAMETHASONE | Edenbridge Pharmaceuticals LLC. | 6b9cf32c-6d60-4853-bbfd-2304ffc2c129 | 2026-01-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Northwind Health Company, LLC | aa30086a-8551-413e-9cf2-6393093cfcfd | 2025-12-26 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Golden State Medical Supply, Inc. | a7455c92-41ce-4e87-e053-2995a90a610f | 2025-12-11 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | a8d6792e-757e-4dc6-adf5-0d9211075428 | 2025-12-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | ANI Pharmaceuticals, Inc. | 5d9b22ca-c619-4ee3-98eb-74544d0d5cb3 | 2025-12-04 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Kesin Pharma Corporation | 43e2a24a-4465-5787-e063-6394a90a0b81 | 2025-11-18 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Kanchan Healthcare Inc | 02f7bf9c-1aa3-4734-8a3e-1f49498055d7 | 2025-11-12 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 429d0d32-a1ff-481b-b4e9-c0b17b3610a1 | 2025-11-01 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Advanced Rx Pharmacy of Tennessee, LLC | 01cfaa3e-5e30-18fa-e063-6394a90a084e | 2025-10-29 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE | DEXAMETHASONE | Advagen Pharma Ltd. | 3c1729db-8ba3-4cba-9eff-ab4ae2c061c2 | 2025-10-22 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 2ceb3a01-f5bb-4538-b5c1-cea400901d02 | 2025-10-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Apotex Corp. | bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2 | 2025-09-17 | Warnings, Adverse reactions | DEXAMETHASONE |
| dexamethasone | DEXAMETHASONE | Major Pharmaceuticals | 5ec5b0e6-7fa8-4afc-97a4-d185484ada8b | 2025-09-08 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | Rising Pharma Holdings, Inc. | 7cf5c17c-a80b-4547-83b2-0d53e2b933f7 | 2025-09-05 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | A-S Medication Solutions | 16c59e9a-8e4f-4300-bbbb-bcc982c18fc8 | 2025-08-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | A-S Medication Solutions | 89af5591-eebf-44e7-827f-ce3b123123e4 | 2025-08-15 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone | DEXAMETHASONE | NuCare Pharmaceuticals,Inc. | 141e16a7-1f3d-3943-e063-6294a90ac5a9 | 2025-07-30 | Warnings, Adverse reactions | DEXAMETHASONE |
| Dexamethasone Intensol | DEXAMETHASONE INTENSOL | Hikma Pharmaceuticals USA, Inc. | b15200fb-1826-472b-a907-e677a272513b | 2025-06-06 | Warnings, Adverse reactions | DEXAMETHASONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71879-001 | Dexycu | dexamethasone | EyePoint Pharmaceuticals US, Inc | NDA | Current |
| 71879-001 | Dexycu | dexamethasone | EyePoint Pharmaceuticals US, Inc | NDA | Current |
| 71879-001 | Dexycu | dexamethasone | EyePoint Pharmaceuticals US, Inc | NDA | Current |
| 71879-001 | Dexycu | dexamethasone | EyePoint Pharmaceuticals US, Inc | NDA | Current |