Application 211420
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXCARBAZEPINE | OXCARBAZEPINE | SUSPENSION;ORAL | 300MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211420-001 | OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | AB | 2021-07-09 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211420-001 | OXCARBAZEPINE | 300MG/5ML | SUSPENSION / ORAL | 2021-07-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211420-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A211420-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A211420-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A211420-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A211420-001 | AB | 1 | 782e0a99824c… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211420-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211420-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A211420-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A211420-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211420-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A211420-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A211420-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211420-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | a2032bcc-2da5-45e5-aa3f-ddbf50909df8 | 2026-08-05 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | a90cd1f1-5258-4b0e-92fd-c4cebe47772b | 2026-08-04 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | ffc8d10c-0049-4fe5-beb8-79cc6a197ede | 2026-07-23 | Warnings, Adverse reactions | OXCARBAZEPINE OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a | 2026-07-21 | Warnings, Adverse reactions | OXCARBAZEPINE OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Cardinal Health 107, LLC | 3e0f8d9f-7659-4524-8f93-6200314356c8 | 2026-07-21 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | ANI Pharmaceuticals, Inc. | 867eaf99-3e31-4f75-bfae-2898804d956d | 2026-07-13 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | 85a9bdee-4d10-4097-ae3d-0bf8d844a11b | 2026-07-08 | Warnings, Adverse reactions | OXCARBAZEPINE OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | American Health Packaging | c0f9df3f-280e-4394-8d7e-ad04803b2635 | 2026-07-02 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Major Pharmaceuticals | b1d54def-057d-4608-bc8f-1d967ac3ec91 | 2026-06-15 | Warnings, Adverse reactions | OXCARBAZEPINE OXCARBAZEPINE |
| oxcarbazepine | OXCARBAZEPINE | Zydus Lifesciences Limited | e23d8a74-b47b-462a-b09c-90bdd58a032e | 2026-06-13 | Warnings, Adverse reactions | oxcarbazepine OXCARBAZEPINE |
| oxcarbazepine | OXCARBAZEPINE | Zydus Pharmaceuticals (USA) Inc. | 5048dc87-2d89-434d-be51-4a97b0ce0601 | 2026-06-13 | Warnings, Adverse reactions | oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | c7718f8b-63e2-40b9-b519-e687cfc2cacf | 2026-06-11 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | 188a48ad-c412-416a-b15b-de5f232740a2 | 2026-06-11 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | 0abe9478-4084-286d-e063-6294a90a9ba7 | 2026-06-10 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | REMEDYREPACK INC. | fcf5044a-8cfd-47d5-9f47-8f6674843c24 | 2026-06-08 | Warnings, Adverse reactions | OXCARBAZEPINE OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Sun Pharmaceutical Industries, Inc. | 7ecd5eef-46f4-407f-9b63-ba65adb3eced | 2026-06-03 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| OXCARBAZEPINE | OXCARBAZEPINE | Camber Pharmaceuticals, Inc. | a18f591b-587e-4769-8ac2-9cfba0b82526 | 2026-05-22 | Warnings, Adverse reactions | OXCARBAZEPINE OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | ASCLEMED USA INC. | c42b2cb2-8b45-488b-bf63-81909a1f06cb | 2026-05-19 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | NCS HealthCare of KY, LLC dba Vangard Labs | a14b5756-4fd1-4ba7-bc23-e1fa9212a148 | 2026-05-18 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |
| Oxcarbazepine | OXCARBAZEPINE | Coupler LLC | 512ab25c-ea79-1e59-e063-6294a90ae9a0 | 2026-05-06 | Warnings, Adverse reactions | Oxcarbazepine OXCARBAZEPINE |