Application 212704
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212704-001 | CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | ||
| A212704-002 | CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | ||
| A212704-003 | CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 |
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 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212704-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212704-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212704-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-09-22 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-02-18 07:12 UTC | 2024-02 | A212704-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212704-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212704-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A212704-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A212704-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A212704-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212704-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212704-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212704-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212704-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212704-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212704-003 | AB | 1 | 9b2671bbb829… |
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 |
|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | Aphena Pharma Solutions - Tennessee, LLC | c1fc31ef-6b2e-4de4-a185-ec44e94e7b40 | 2016-06-02 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.