Iclusig

{
  "unii": {
    "unii": "96R6PU3D8J",
    "rxcui": "1364953",
    "inchikey": "BWTNNZPNKQIADY-UHFFFAOYSA-N",
    "display_name": "PONATINIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "16d804b6-4957-43ee-b18c-3b36ec37c5ac": {
      "match": "brand_token",
      "title": "ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "19",
      "published_date": "2026-05-07"
    }
  },
  "productid": "63020-534_1987d030-31ce-4d26-9871-0a3e7ee4e522",
  "productndc": "63020-534",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203469",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Dec 14, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 45MG BASE",
        "product_no": "002",
        "approval_date": "Dec 14, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Apr 23, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Dec 18, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PONATINIB HYDROCHLORIDE",
  "proprietary_name": "Iclusig",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203469",
  "marketing_category": "NDA",
  "nonproprietary_name": "ponatinib hydrochloride",
  "start_marketing_date": "20121214",
  "active_numerator_strength": "45"
}