Application 214328
- Type
- ANDA
- Sponsor
- VGYAAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214328-001 | CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 |
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 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2021-08-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | AB | 2021-08-16 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214328-001 | CARBAMAZEPINE | 200MG | TABLET / ORAL | 2021-08-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A214328-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A214328-001 | AB | 1 | 782e0a99824c… |
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 | Northstar Rx LLC | c91a5a1b-5481-445b-86e8-f10109ac3937 | 2026-08-26 | Boxed warning, Warnings, Adverse reactions | carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Ascend Laboratories, LLC | f0a254c5-bd33-4b14-b9f0-830b3438f5c6 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Tegretol | CARBAMAZEPINE | Novartis Pharmaceuticals Corporation | 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE |
| Carbatrol | CARBAMAZEPINE | Takeda Pharmaceuticals America, Inc. | bc03e499-5bac-4293-bff4-6864153a624d | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Unichem Pharmaceuticals (USA), Inc. | 50ba2042-fc67-4266-a773-a30f07649a5a | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Umedica Laboratories USA Inc. | 48080efd-1781-4585-83f8-c43957ac63b3 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Umedica Laboratories USA Inc. | f3465f71-8931-43b6-baea-eac7046a4400 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | 52cf3ba9-0a7c-4809-830e-af93d1532726 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| carbamazepine | CARBAMAZEPINE | Zydus Lifesciences Limited | d10e5f83-56db-4bc9-8c51-150a2e3e20ea | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | carbamazepine CARBAMAZEPINE |
| carbamazepine | CARBAMAZEPINE | Zydus Pharmaceuticals (USA) Inc. | c5e4a25a-0137-4327-96f5-15735891ad5c | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | 7c4860c1-daba-4e0f-97fd-d30cbc8603a2 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | 97e6e175-75e8-437b-b457-ddb1ae4e857d | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | American Health Packaging | 7108d630-89bc-4815-b6fb-a1f4676c496e | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 9471b7fb-29d3-4009-9d0f-f20c27351db5 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 40bf2923-24b1-4af1-8d20-03cf06b455a5 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | 2a8c7366-ce89-47ce-8123-96f26812fca0 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | d0121be3-b904-41d3-a81a-292aa4176491 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Bionpharma Inc., | 138d9ed1-2f8e-d19d-e063-6394a90a695d | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 8cc7288c-4a7e-417c-9ceb-0e0f8aeeacb3 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72664-218 | Carbamazepine | Carbamazepine | VGYAAN Pharmaceuticals LLC | ANDA | Current |