TEPADINA

{
  "unii": {
    "unii": "905Z5W3GKH",
    "rxcui": "10473",
    "inchikey": "FOCVUCIESVLUNU-UHFFFAOYSA-N",
    "display_name": "THIOTEPA",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
  "spl_meta": {
    "559e353c-2dc0-16ba-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "TEPADINA (THIOTEPA) INJECTION, POWDER, FOR SOLUTION TEPADINA (THIOTEPA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "30",
      "published_date": "2026-02-16"
    }
  },
  "productid": "70121-1687_4f44c872-f02d-48cc-b2a4-4e05d2422b72",
  "productndc": "70121-1687",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "208264",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "15MG/VIAL",
        "product_no": "001",
        "approval_date": "Jan 26, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "002",
        "approval_date": "Jan 26, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Apr 10, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Jan 15, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THIOTEPA",
  "proprietary_name": "TEPADINA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208264",
  "marketing_category": "NDA",
  "nonproprietary_name": "thiotepa",
  "start_marketing_date": "20250418",
  "active_numerator_strength": "400"
}