Application 203324
- Type
- NDA
- Sponsor
- AVEDRO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHOTREXA | RIBOFLAVIN 5'-PHOSPHATE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 0.146% | Yes | Yes |
| 002 | PHOTREXA VISCOUS IN DEXTRAN 20% | RIBOFLAVIN 5'-PHOSPHATE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 0.146% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203324-001 | PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA | RIBOFLAVIN 5'-PHOSPHATE SODIUM | EQ 0.146% BASE/ML;EQ 0.146% BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N203324-001 | PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA | EQ 0.146% BASE/ML;EQ 0.146% BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N203324-002 | PHOTREXA VISCOUS IN DEXTRAN 20% | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203324-001 | PHOTREXA | 0.146% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2016-04-15 | 87673890dc5c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203324-001 | ODE-116 | 2023-04-15 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203324-001 | ODE-121 | 2023-07-15 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203324-002 | ODE-116 | 2023-04-15 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203324-002 | ODE-121 | 2023-07-15 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N203324-001 | ODE-116 | 2023-04-15 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N203324-001 | ODE-121 | 2023-07-15 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N203324-002 | ODE-116 | 2023-04-15 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N203324-002 | ODE-121 | 2023-07-15 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N203324-001 | ODE-116 | 2023-04-15 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N203324-001 | ODE-121 | 2023-07-15 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N203324-002 | ODE-116 | 2023-04-15 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N203324-002 | ODE-121 | 2023-07-15 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-001 | NP | 2019-04-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-001 | ODE-116 | 2023-04-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-001 | ODE-121 | 2023-07-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-002 | NP | 2019-04-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-002 | ODE-116 | 2023-04-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N203324-002 | ODE-121 | 2023-07-15 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N203324-001 | ODE-116 | 2023-04-15 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N203324-001 | ODE-121 | 2023-07-15 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N203324-002 | ODE-116 | 2023-04-15 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N203324-002 | ODE-121 | 2023-07-15 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N203324-001 | ODE-116 | 2023-04-15 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N203324-001 | ODE-121 | 2023-07-15 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N203324-002 | ODE-116 | 2023-04-15 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N203324-002 | ODE-121 | 2023-07-15 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203324-001 | ODE-116 | 2023-04-15 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203324-001 | ODE-121 | 2023-07-15 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203324-002 | ODE-116 | 2023-04-15 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203324-002 | ODE-121 | 2023-07-15 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N203324-001 | ODE-116 | 2023-04-15 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N203324-001 | ODE-121 | 2023-07-15 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N203324-002 | ODE-116 | 2023-04-15 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N203324-002 | ODE-121 | 2023-07-15 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N203324-001 | ODE-116 | 2023-04-15 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N203324-001 | ODE-121 | 2023-07-15 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N203324-002 | ODE-116 | 2023-04-15 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N203324-002 | ODE-121 | 2023-07-15 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N203324-001 | ODE-116 | 2023-04-15 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N203324-001 | ODE-121 | 2023-07-15 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Photrexa Cross-linking Kit | RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC | Glaukos Corporation | f82cfe92-1a24-11e3-8ffd-0800200c9a66 | 2026-07-24 | Warnings, Adverse reactions | 203324 NDA203324 25357-025 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25357-022 | Photrexa Viscous | riboflavin 5-phosphate in 20% dextran ophthalmic | Glaukos Corporation | NDA | Current |
| 25357-022 | Photrexa Viscous | riboflavin 5-phosphate in 20% dextran ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-022 | Photrexa Viscous | riboflavin 5-phosphate in 20% dextran ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-022 | Photrexa Viscous | riboflavin 5-phosphate in 20% dextran ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-023 | Photrexa | riboflavin 5-phosphate ophthalmic | Glaukos Corporation | NDA | Current |
| 25357-023 | Photrexa | riboflavin 5-phosphate ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-023 | Photrexa | riboflavin 5-phosphate ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-023 | Photrexa | riboflavin 5-phosphate ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-025 | Photrexa Cross-linking Kit | riboflavin 5-phosphate ophthalmic | Glaukos Corporation | NDA | Current |
| 25357-025 | Photrexa Cross-linking Kit | riboflavin 5-phosphate ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-025 | Photrexa Cross-linking Kit | riboflavin 5-phosphate ophthalmic | Avedro, Inc. | NDA | Current |
| 25357-025 | Photrexa Cross-linking Kit | riboflavin 5-phosphate ophthalmic | Avedro, Inc. | NDA | Current |