Application 040298
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | CAPSULE;ORAL | 100MG EXTENDED | No | No |
| 002 | PHENYTEK | PHENYTOIN SODIUM | CAPSULE;ORAL | 200MG EXTENDED | No | No |
| 003 | PHENYTEK | PHENYTOIN SODIUM | CAPSULE;ORAL | 300MG EXTENDED | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040298-001 | EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | ||
| A040298-002 | PHENYTEK | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | ||
| A040298-003 | PHENYTEK | PHENYTOIN SODIUM | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 |
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 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040298-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040298-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040298-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040298-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040298-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040298-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040298-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040298-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040298-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040298-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040298-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040298-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040298-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040298-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040298-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040298-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040298-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040298-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040298-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040298-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040298-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040298-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040298-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040298-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040298-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040298-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040298-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040298-002 | AB | 1 | 8869cabd3fbd… |
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 |
|---|---|---|---|---|---|---|
| Phenytek | EXTENDED PHENYTOIN SODIUM | Coupler LLC | 2cdc1905-8f45-1275-e063-6394a90a2ab7 | 2025-01-29 | Warnings, Adverse reactions | 040298 ANDA040298 |
| Phenytek | EXTENDED PHENYTOIN SODIUM | Mylan Pharmaceuticals Inc. | 0f94c791-8b07-4b41-927e-c9f28bec5f60 | 2024-10-15 | Warnings, Adverse reactions | 040298 ANDA040298 0378-2670 0378-3750 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1560 | Phenytoin Sodium | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1560 | Phenytoin Sodium | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1560 | Phenytoin Sodium | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1560 | Phenytoin Sodium | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1560 | Phenytoin Sodium | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1560 | Phenytoin Sodium | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2670 | Phenytek | extended phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2670 | Phenytek | extended phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2670 | Phenytek | extended phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2670 | Phenytek | extended phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2670 | Phenytek | extended phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2670 | Phenytek | extended phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3750 | Phenytek | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3750 | Phenytek | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3750 | Phenytek | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3750 | Phenytek | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3750 | Phenytek | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3750 | Phenytek | phenytoin sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-1343 | Phenytoin Sodium | phenytoin sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 51079-905 | Phenytoin Sodium | phenytoin sodium | Mylan Institutional Inc. | ANDA | Current |
| 51079-905 | Phenytoin Sodium | phenytoin sodium | Mylan Institutional Inc. | ANDA | Current |
| 51079-905 | Phenytoin Sodium | phenytoin sodium | Mylan Institutional Inc. | ANDA | Current |
| 51079-905 | Phenytoin Sodium | phenytoin sodium | Mylan Institutional Inc. | ANDA | Current |
| 53808-0652 | Phenytoin Sodium | phenytoin sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-5496 | Phenytoin Sodium | phenytoin sodium | Cardinal Health | ANDA | Current |
| 55154-5496 | Phenytoin Sodium | phenytoin sodium | Cardinal Health | ANDA | Current |
| 63629-2552 | Phenytoin Sodium | phenytoin sodium | Bryant Ranch Prepack | ANDA | Current |
| 67544-517 | Phenytoin Sodium | phenytoin sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 67544-517 | Phenytoin Sodium | phenytoin sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |