Application 088519
- Type
- ANDA
- Sponsor
- SMITH AND NEPHEW
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | INJECTABLE;INJECTION | 50MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088519-001 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A088519-001 | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE / INJECTION | 1984-12-19 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Phenytoin Sodium | PHENYTOIN SODIUM | A-S Medication Solutions | ef4e97a7-cd18-47a9-a016-2eca5481a87e | 2026-07-24 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Extended Phenytoin Sodium | PHENYTOIN SODIUM | REMEDYREPACK INC. | 363cd347-d25e-42b9-9ce7-30642f3cb353 | 2026-06-25 | Warnings, Adverse reactions | PHENYTOIN SODIUM |
| Extended Phenytoin Sodium | PHENYTOIN SODIUM | Amneal Pharmaceuticals LLC | 7e467c02-49a0-4b62-b537-430fdfa4f10e | 2026-05-26 | Warnings, Adverse reactions | PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | REMEDYREPACK INC. | e33ce05d-9c60-4ede-8b13-e8c41a3de25d | 2026-05-19 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Coupler LLC | 51b660c3-7d88-77b2-e063-6294a90a0286 | 2026-05-13 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Golden State Medical Supply, Inc. | 36262a4c-33f1-40a5-e063-6394a90ad36a | 2026-04-21 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | REMEDYREPACK INC. | 844a16db-17d5-44da-819d-54f3e19cfec2 | 2026-03-25 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Sun Pharmaceutical Industries, Inc. | 601f7353-225d-4a5d-9810-3869c2c21874 | 2026-03-17 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | AvPAK | 4c2542b8-ac54-e85d-e063-6294a90a759b | 2026-03-03 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | DIRECT RX | df0bf42b-ce9a-42c3-8c24-46f1ea3bd214 | 2026-02-27 | Warnings, Adverse reactions | PHENYTOIN SODIUM PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Proficient Rx LP | f4353734-29b0-4027-824d-2fc97f778c67 | 2026-02-01 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Major Pharmaceuticals | 46d5c0d1-a97b-46d9-8cf4-994780673337 | 2025-12-09 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | ProPharma Distribution | 43060ca9-58a7-3371-e063-6294a90a5799 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Henry Schein, Inc. | 889dd22c-46f0-48d0-b18e-a3783c5fa653 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 3bc82d23-3950-f181-e063-6394a90ad565 | 2025-09-02 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Extended Phenytoin Sodium | PHENYTOIN SODIUM | Bryant Ranch Prepack | a9a1059e-63a2-486e-aa50-eda388f79525 | 2025-06-11 | Warnings, Adverse reactions | PHENYTOIN SODIUM |
| Extended Phenytoin Sodium | PHENYTOIN SODIUM | American Health Packaging | 5b64cb11-673a-41ec-9b2a-1e194ae5eb0c | 2025-02-06 | Warnings, Adverse reactions | PHENYTOIN SODIUM |
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | Henry Schein, Inc. | a52cf1bd-dc1f-47be-aba8-29066d9a50fb | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | PHENYTOIN SODIUM PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 29b8d0a2-a96e-46a5-e063-6394a90a7113 | 2024-12-20 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |
| Phenytoin Sodium | PHENYTOIN SODIUM | Bryant Ranch Prepack | 6b4c2885-eae0-4c88-ada3-62a699df1dbb | 2024-11-01 | Warnings, Adverse reactions | Phenytoin Sodium PHENYTOIN SODIUM |