FDA.reportPublic FDA data

Application 219241

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXCARBAZEPINEOXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL150MGNoNo
002OXCARBAZEPINEOXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL300MGNoNo
003OXCARBAZEPINEOXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL600MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219241-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-30
A219241-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-30
A219241-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-30

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 22:38:342026-08A219241-001OXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A219241-002OXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A219241-003OXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A219241-001OXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A219241-002OXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A219241-003OXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219241-001OXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219241-002OXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219241-003OXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219241-001OXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219241-002OXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219241-003OXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A219241-001OXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219241-002OXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219241-003OXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219241-001OXCARBAZEPINE150MGTABLET, EXTENDED RELEASE / ORAL2025-04-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219241-002OXCARBAZEPINE300MGTABLET, EXTENDED RELEASE / ORAL2025-04-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219241-003OXCARBAZEPINE600MGTABLET, EXTENDED RELEASE / ORAL2025-04-30a50c72e98297…

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 3 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.b9db5c45-8b51-449b-b4af-1a235c08f1892025-12-11Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEGlenmark Pharmaceuticals Inc., USA1c713b59-a628-42e6-b166-ae71c39132842025-12-03Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAjanta Pharma USA Inc.d947e9b1-2a15-4048-bb4e-fe56b68518482025-11-30Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEBionpharma Inc.ec033897-21b4-4d08-83de-042783e892512025-11-28Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.a1b6a698-f7d9-4adb-9e38-b63e7a85e2b32025-10-24Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.1176d5f5-3447-4925-aed8-1a1cb4b5989d2025-10-13Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAmneal Pharmaceuticals LLC2515391e-3a88-4226-92e5-f641c8409fe52025-10-01Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINECoupler LLC3f15c889-4386-850b-e063-6294a90a8dbf2025-09-18Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.e156339c-f79e-4a20-b9da-f50bea9482132025-09-05Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
oxcarbazepineOXCARBAZEPINEMacleods Pharmaceuticals Limited962098cc-2d84-4723-a296-b110f1fd659e2025-08-29Warnings, Adverse reactionsName fallback
brand name: oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAscend Laboratories, LLC3f36f519-c30c-4929-afa0-9844dc531e3f2025-07-22Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEMarlex Pharmaceuticals, Incd3684d55-0564-4849-bdf6-b91f22a3e28c2025-06-25Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEIngenus Pharmaceuticals, LLC70798ca9-0eda-49c0-8a7c-b775b6ae3d692025-04-12Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEProficient Rx LP433d9d03-a36e-42c6-8e4d-f333ed60e45a2025-03-01Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINENorthStar RxLLC1746d95f-c529-45ba-a520-0c135e8edda82025-02-03Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEDirectRxdbea45c2-e166-b557-e053-2995a90a76432025-01-22Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEBryant Ranch Prepack23137a89-cbd0-4a5f-8220-f26b7ba543302025-01-21Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAvPAKfd8da0e9-d69b-7587-e053-6294a90a33c02025-01-09Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEEPIC PHARMA, LLC62ab716b-f05f-454d-95b3-1a382cdf72262025-01-07Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINENovadoz Pharmaceuticals LLC03bec567-a9c3-4d82-9679-fec5324d0df62024-11-18Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

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