Application 077272
- Type
- ANDA
- Sponsor
- TORRENT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 300MG | No | No |
| 004 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077272-001 | CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | ||
| A077272-002 | CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | |
| A077272-003 | CARBAMAZEPINE | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | ||
| A077272-004 | CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077272-002 | AB |
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 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | 2005-12-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | AB | 2005-12-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | AB | 2005-12-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | AB | 2005-12-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077272-001 | CARBAMAZEPINE | 100MG | TABLET / ORAL | AB | 2005-12-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077272-002 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2005-12-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077272-003 | CARBAMAZEPINE | 300MG | TABLET / ORAL | 2005-12-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077272-004 | CARBAMAZEPINE | 400MG | TABLET / ORAL | 2005-12-07 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077272-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077272-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077272-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077272-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077272-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077272-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077272-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077272-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077272-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077272-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077272-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077272-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077272-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077272-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077272-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077272-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077272-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077272-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077272-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077272-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077272-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077272-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077272-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077272-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077272-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077272-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077272-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077272-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077272-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077272-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077272-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077272-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077272-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077272-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077272-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077272-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077272-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077272-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077272-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077272-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | 97e6e175-75e8-437b-b457-ddb1ae4e857d | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 077272 ANDA077272 13668-268 |
| CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | 2a8c7366-ce89-47ce-8123-96f26812fca0 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 077272 ANDA077272 0904-6172 |
| Carbamazepine | CARBAMAZEPINE | Cardinal Health 107, LLC | 232ef732-ee6d-4ac7-8e78-c619b611fbbe | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 077272 ANDA077272 55154-1396 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-4515 | CARBAMAZEPINE | CARBAMAZEPINE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6172 | CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | ANDA | Current |
| 0904-6172 | CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | ANDA | Current |
| 0904-6172 | CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | ANDA | Current |
| 0904-6172 | CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | ANDA | Current |
| 13668-268 | CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-268 | CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-268 | CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-268 | CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-268 | CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 49999-616 | CARBAMAZEPINE | CARBAMAZEPINE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55154-1396 | Carbamazepine | Carbamazepine | Cardinal Health | ANDA | Current |
| 55154-1396 | Carbamazepine | Carbamazepine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-1396 | Carbamazepine | Carbamazepine | Cardinal Health | ANDA | Current |
| 58118-0268 | CARBAMAZEPINE | CARBAMAZEPINE | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0268 | CARBAMAZEPINE | CARBAMAZEPINE | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0268 | CARBAMAZEPINE | CARBAMAZEPINE | Clinical Solutions Wholesale | ANDA | Current |
| 60687-490 | Carbamazepine | Carbamazepine | American Health Packaging | ANDA | Current |
| 66267-278 | CARBAMAZEPINE | CARBAMAZEPINE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-278 | CARBAMAZEPINE | CARBAMAZEPINE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-096 | CARBAMAZEPINE | CARBAMAZEPINE | Contract Pharmacy Services-PA | ANDA | Current |
| 68788-9492 | CARBAMAZEPINE | CARBAMAZEPINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9492 | CARBAMAZEPINE | CARBAMAZEPINE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0902 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2456 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2456 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2456 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2456 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2489 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2489 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2489 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2489 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2489 | CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | ANDA | Current |
| 71335-0462 | CARBAMAZEPINE | CARBAMAZEPINE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0462 | CARBAMAZEPINE | CARBAMAZEPINE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0462 | CARBAMAZEPINE | CARBAMAZEPINE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0462 | CARBAMAZEPINE | CARBAMAZEPINE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0462 | CARBAMAZEPINE | CARBAMAZEPINE | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44618 | ORIG | 2008-02-01 |