GRAFAPEX

{
  "unii": {
    "unii": "CO61ER3EPI",
    "rxcui": "38508",
    "inchikey": "YCPOZVAOBBQLRI-WDSKDSINSA-N",
    "display_name": "TREOSULFAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2d06b03c-17aa-0492-e063-6294a90abd8f": {
      "match": "brand_token",
      "title": "GRAFAPEX (TREOSULFAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDEXUS PHARMA, INC.]",
      "spl_version": "1",
      "published_date": "2025-02-03"
    }
  },
  "productid": "59137-365_2d06b03c-17aa-0492-e063-6294a90abd8f",
  "productndc": "59137-365",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214759",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/VIAL",
        "product_no": "001",
        "approval_date": "Jan 21, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5GM/VIAL",
        "product_no": "002",
        "approval_date": "Jan 21, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TREOSULFAN",
  "proprietary_name": "GRAFAPEX",
  "active_ingred_unit": "mg/5g",
  "application_number": "NDA214759",
  "marketing_category": "NDA",
  "nonproprietary_name": "treosulfan",
  "start_marketing_date": "20250128",
  "active_numerator_strength": "5000"
}