FDA.reportPublic FDA data

Application 214328

Type
ANDA
Sponsor
VGYAAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214328-001CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORAL2021-08-16

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1684e616aacf4f…
2026-08-18 06:07:402026-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214328-001CARBAMAZEPINE200MGTABLET / ORALAB2021-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214328-001CARBAMAZEPINE200MGTABLET / ORALAB2021-08-16782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214328-001CARBAMAZEPINE200MGTABLET / ORAL2021-08-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-03-09 01:35 UTC2022-03A214328-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214328-001AB1782e0a99824c…

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.

Matched openFDA labels page 4 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack2d2c5317-4072-477b-a4e2-f6765fc716572025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
EQUETROCARBAMAZEPINEValidus Pharmaceuticals LLCbe478f3c-40f6-47cc-8ab9-f420a9372b1c2025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack46eef194-760d-43ea-86c5-341927277c912025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepack45b355e6-9c19-4138-a1f8-53508e88f5a92025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBAMAZEPINE
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack4db57051-13bb-4038-ae58-e4d7f541450d2025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEAlembic Pharmaceuticals Limited1fc170d7-db1a-486d-8c10-faa6e3da3b1e2025-07-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack34f75728-b9e8-48e7-e063-6394a90afc312025-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINECoupler LLC33ed4e35-8be2-d0ea-e063-6394a90a06a62025-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINECoupler LLC33edb22f-f357-ec0f-e063-6394a90a7bc32025-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Limiteda742c03d-10b1-48e2-8df1-48967395ae062025-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBAMAZEPINE
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINECoupler, LLC30b75584-3a1c-c125-e063-6294a90acaa72025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEAtlantic Biologicals Corps25939406-a836-43cd-9301-56808e9b31ec2025-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEA-S Medication Solutions047bc284-060a-4db9-bf37-75d10f95a0a62025-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINECoupler LLC2d936849-9c80-5b7f-e063-6294a90aaa6c2025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEdirect rxb56dd9c8-1bca-21e3-e053-2995a90a3e6e2025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBAMAZEPINE
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackebcffad6-da03-43f4-a75b-7de13e94bb7d2024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEChartwell RX, LLC8d5ace90-983b-48c4-baf1-b44f6af146de2024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEAphena Pharma Solutions - Tennessee, LLC697f3e5a-c84b-44a6-b9f3-15e7d9bb63952024-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEUpsher-Smith Laboratories, LLC282c954f-e34a-4bd5-b5eb-771e3c56936f2023-10-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carbamazepine
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEProficient Rx LPbf61798e-c07e-4959-909a-2b4c2c83b5322019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBAMAZEPINE
generic name: CARBAMAZEPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72664-218CarbamazepineCarbamazepineVGYAAN Pharmaceuticals LLCANDACurrent