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 1.

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
2026-02-19 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 1 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ffc8d10c-0049-4fe5-beb8-79cc6a197ede2026-07-23Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a2026-07-21Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECardinal Health 107, LLC3e0f8d9f-7659-4524-8f93-6200314356c82026-07-21Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEANI Pharmaceuticals, Inc.867eaf99-3e31-4f75-bfae-2898804d956d2026-07-13Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.85a9bdee-4d10-4097-ae3d-0bf8d844a11b2026-07-08Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAmerican Health Packagingc0f9df3f-280e-4394-8d7e-ad04803b26352026-07-02Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticalsb1d54def-057d-4608-bc8f-1d967ac3ec912026-06-15Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
oxcarbazepineOXCARBAZEPINEZydus Lifesciences Limitede23d8a74-b47b-462a-b09c-90bdd58a032e2026-06-13Warnings, Adverse reactionsName fallback
brand name: oxcarbazepine
generic name: OXCARBAZEPINE
oxcarbazepineOXCARBAZEPINEZydus Pharmaceuticals (USA) Inc.5048dc87-2d89-434d-be51-4a97b0ce06012026-06-13Warnings, Adverse reactionsName fallback
brand name: oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.c7718f8b-63e2-40b9-b519-e687cfc2cacf2026-06-11Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.188a48ad-c412-416a-b15b-de5f232740a22026-06-11Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.0abe9478-4084-286d-e063-6294a90a9ba72026-06-10Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.fcf5044a-8cfd-47d5-9f47-8f6674843c242026-06-08Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINESun Pharmaceutical Industries, Inc.7ecd5eef-46f4-407f-9b63-ba65adb3eced2026-06-03Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINECamber Pharmaceuticals, Inc.a18f591b-587e-4769-8ac2-9cfba0b825262026-05-22Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEASCLEMED USA INC.c42b2cb2-8b45-488b-bf63-81909a1f06cb2026-05-19Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINENCS HealthCare of KY, LLC dba Vangard Labsa14b5756-4fd1-4ba7-bc23-e1fa9212a1482026-05-18Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECoupler LLC512ab25c-ea79-1e59-e063-6294a90ae9a02026-05-06Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEUmedica Laboratories USA Inc.e46d4654-76bc-4c33-ac2b-e89ae11b76972026-05-05Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECoupler LLC51008af2-39ac-546c-e063-6294a90a758f2026-05-04Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE