Augtyro

{
  "unii": {
    "unii": "08O3FQ4UNP",
    "rxcui": null,
    "inchikey": "FIKPXCOQUIZNHB-WDEREUQCSA-N",
    "display_name": "REPOTRECTINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fb526827-40ba-4462-94cf-179ae3b0cb8a": {
      "match": "brand_token",
      "title": "AUGTYRO (REPOTRECTINIB) CAPSULE [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "5",
      "published_date": "2024-12-06"
    }
  },
  "productid": "0003-4160_03987a7d-5ac9-4c41-9a48-c9aee4dd13de",
  "productndc": "0003-4160",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218213",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Nov 15, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "160MG",
        "product_no": "002",
        "approval_date": "Jun 11, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REPOTRECTINIB",
  "proprietary_name": "Augtyro",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218213",
  "marketing_category": "NDA",
  "nonproprietary_name": "repotrectinib",
  "start_marketing_date": "20241101",
  "active_numerator_strength": "160"
}