FDA.reportPublic FDA data

Application 205444

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

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.

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 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxcarbazepineOXCARBAZEPINEZameer Pharmaceuticals LLC8841174a-9f4b-424f-a50d-01478f2aeb292026-08-26Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINECardinal Health 107, LLC4ebcb0e5-1c93-4b3f-8749-6835c56afce52026-08-12Warnings, Adverse reactionsName fallback
brand name: OXCARBAZEPINE
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a2032bcc-2da5-45e5-aa3f-ddbf50909df82026-08-05Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a90cd1f1-5258-4b0e-92fd-c4cebe47772b2026-08-04Warnings, Adverse reactionsName fallback
brand name: Oxcarbazepine
generic name: OXCARBAZEPINE
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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55403ORIG2018-09-07