Idamycin PFS

{
  "unii": {
    "unii": "5VV3MDU5IE",
    "rxcui": "82124",
    "inchikey": "JVHPTYWUBOQMBP-RVFAQHLVSA-N",
    "display_name": "IDARUBICIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "0a5a6d93-cc1e-4d7f-8da1-446c134503b3": {
      "match": "brand_token",
      "title": "IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "27",
      "published_date": "2026-04-17"
    }
  },
  "productid": "0013-2576_d504ef4f-8fe8-447e-8fb3-30846fb2e486",
  "productndc": "0013-2576",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "050734",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5MG/5ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 17, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 17, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/20ML (1MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 17, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IDARUBICIN HYDROCHLORIDE",
  "proprietary_name": "Idamycin PFS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA050734",
  "marketing_category": "NDA",
  "nonproprietary_name": "idarubicin hydrochloride",
  "start_marketing_date": "19970217",
  "active_numerator_strength": "1"
}