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 2 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
OxcarbazepineOXCARBAZEPINEUmedica Laboratories USA Inc.e46d4654-76bc-4c33-ac2b-e89ae11b76972026-05-05Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECoupler LLC51008af2-39ac-546c-e063-6294a90a758f2026-05-04Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticals567c0777-9bc5-45a9-ba25-959dd76d0e052026-04-30Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECoupler LLC50873ef7-3deb-7386-e063-6394a90a9c192026-04-28Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEBryant Ranch Prepack87f53c04-075c-4d09-925a-0faeaa14f3f92026-04-23Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.54fb494e-bce4-442d-954a-757f9851e81e2026-04-13Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEBryant Ranch Prepack148b90ba-236a-47cc-b171-22dd7f8f8e0a2026-03-20Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINENorthStar RxLLC20d826cd-fa4a-4570-9e10-9d7d10fb725b2026-03-17Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAdvagen Pharma Limitedb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a2026-02-24Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAdvagen Pharma Ltd.ab4c1f36-82fa-40a2-a31a-227875d0f3822026-02-04Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.244f9a68-5ab4-46b8-a01f-538572fd3c5f2026-02-03Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b2026-02-03Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECamber Pharmaceuticals, Inc.fe49a773-562c-4da6-96b7-bba52f4d61e22026-01-30Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEAdvagen Pharma Ltd4ef6a941-a017-40f2-a50a-ab66c43b33472026-01-13Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEChartwell RX, LLCc2affa00-1d57-4d85-8db3-745191b4714d2026-01-08Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINECoupler LLC47b92168-6832-1e0b-e063-6394a90a079a2026-01-06Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEChartwell Governmental & Specialty RX, LLC.e74bb389-8426-4ffc-a14b-a5990de6d0d42025-12-26Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
TrileptalOXCARBAZEPINENovartis Pharmaceuticals Corporation4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b2025-12-16Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

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