Banzel

{
  "unii": {
    "unii": "WFW942PR79",
    "rxcui": "69036",
    "inchikey": "POGQSBRIGCQNEG-UHFFFAOYSA-N",
    "display_name": "RUFINAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0a3fa925-1abd-458a-bd57-4ae780a1ef2d": {
      "match": "brand_token",
      "title": "BANZEL (RUFINAMIDE) TABLET, FILM COATED BANZEL (RUFINAMIDE) SUSPENSION [EISAI INC.]",
      "spl_version": "45",
      "published_date": "2024-11-18"
    }
  },
  "productid": "62856-583_0cc6f13a-0289-45f7-980e-3196d7489d75",
  "productndc": "62856-583",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021911",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Nov 14, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Nov 14, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Nov 14, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RUFINAMIDE",
  "proprietary_name": "Banzel",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021911",
  "marketing_category": "NDA",
  "nonproprietary_name": "rufinamide",
  "start_marketing_date": "20081114",
  "active_numerator_strength": "400"
}