Galafold

{
  "unii": {
    "unii": "CLY7M0XD20",
    "rxcui": "2054264",
    "inchikey": "ZJIHMALTJRDNQI-OLALXQGDSA-N",
    "display_name": "MIGALASTAT HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "66dbd928-0f1c-48b1-a832-54e4abd9f1db": {
      "match": "brand_token",
      "title": "GALAFOLD (MIGALASTAT HYDROCHLORIDE) CAPSULE [AMICUS THERAPEUTICS US, LLC]",
      "spl_version": "18",
      "published_date": "2025-09-15"
    }
  },
  "productid": "71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139",
  "productndc": "71904-100",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208623",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 123MG BASE",
        "product_no": "001",
        "approval_date": "Aug 10, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIGALASTAT HYDROCHLORIDE",
  "proprietary_name": "Galafold",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208623",
  "marketing_category": "NDA",
  "nonproprietary_name": "migalastat hydrochloride",
  "start_marketing_date": "20180810",
  "active_numerator_strength": "123"
}