AKEEGA

{
  "unii": {
    "unii": "EM5OCB9YJ6",
    "rxcui": "1100071",
    "inchikey": "UVIQSJCZCSLXRZ-UBUQANBQSA-N",
    "display_name": "ABIRATERONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8245a990-3268-4613-b5c5-9537858a1eb9": {
      "match": "brand_token",
      "title": "AKEEGA (NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]",
      "spl_version": "3",
      "published_date": "2025-12-22"
    }
  },
  "productid": "57894-050_463bff67-d7cf-a132-e063-6394a90abe1d",
  "productndc": "57894-050",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216793",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG;EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Aug 11, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG;EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Aug 11, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABIRATERONE ACETATE; NIRAPARIB TOSYLATE MONOHYDRATE",
  "proprietary_name": "AKEEGA",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA216793",
  "marketing_category": "NDA",
  "nonproprietary_name": "NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE",
  "start_marketing_date": "20230811",
  "active_numerator_strength": "500; 50"
}