FDA.reportPublic FDA data

Application 219404

Type
ANDA
Sponsor
LUPIN LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002OXCARBAZEPINE EXTENDED RELEASE TABLETSOXCARBAZEPINETABLET;EXTENDED RELEASE300MGNoNo
003OXCARBAZEPINE EXTENDED RELEASE TABLETSOXCARBAZEPINETABLET;EXTENDED RELEASE600MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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.a2032bcc-2da5-45e5-aa3f-ddbf50909df82026-08-05Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a90cd1f1-5258-4b0e-92fd-c4cebe47772b2026-08-04Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ffc8d10c-0049-4fe5-beb8-79cc6a197ede2026-07-23Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a2026-07-21Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECardinal Health 107, LLC3e0f8d9f-7659-4524-8f93-6200314356c82026-07-21Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEANI Pharmaceuticals, Inc.867eaf99-3e31-4f75-bfae-2898804d956d2026-07-13Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.85a9bdee-4d10-4097-ae3d-0bf8d844a11b2026-07-08Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAmerican Health Packagingc0f9df3f-280e-4394-8d7e-ad04803b26352026-07-02Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticalsb1d54def-057d-4608-bc8f-1d967ac3ec912026-06-15Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
oxcarbazepineOXCARBAZEPINEZydus Lifesciences Limitede23d8a74-b47b-462a-b09c-90bdd58a032e2026-06-13Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
oxcarbazepineOXCARBAZEPINEZydus Pharmaceuticals (USA) Inc.5048dc87-2d89-434d-be51-4a97b0ce06012026-06-13Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.c7718f8b-63e2-40b9-b519-e687cfc2cacf2026-06-11Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.188a48ad-c412-416a-b15b-de5f232740a22026-06-11Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.0abe9478-4084-286d-e063-6294a90a9ba72026-06-10Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.fcf5044a-8cfd-47d5-9f47-8f6674843c242026-06-08Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINESun Pharmaceutical Industries, Inc.7ecd5eef-46f4-407f-9b63-ba65adb3eced2026-06-03Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINECamber Pharmaceuticals, Inc.a18f591b-587e-4769-8ac2-9cfba0b825262026-05-22Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEASCLEMED USA INC.c42b2cb2-8b45-488b-bf63-81909a1f06cb2026-05-19Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINENCS HealthCare of KY, LLC dba Vangard Labsa14b5756-4fd1-4ba7-bc23-e1fa9212a1482026-05-18Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECoupler LLC512ab25c-ea79-1e59-e063-6294a90ae9a02026-05-06Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE