PROMACTA

{
  "unii": {
    "unii": "4U07F515LG",
    "rxcui": "735651",
    "inchikey": "PLILLUUXAVKBPY-SBIAVEDLSA-N",
    "display_name": "ELTROMBOPAG OLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7714a0ed-34bb-46e6-a0a5-b363908b22c2": {
      "match": "brand_token",
      "title": "PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "31",
      "published_date": "2025-12-19"
    }
  },
  "productid": "0078-0685_b8a1cc48-9aaf-486a-9305-090acccb5c02",
  "productndc": "0078-0685",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022291",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG ACID",
        "product_no": "001",
        "approval_date": "Nov 20, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG ACID",
        "product_no": "002",
        "approval_date": "Nov 20, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG ACID",
        "product_no": "003",
        "approval_date": "Sep 8, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 12.5MG ACID",
        "product_no": "004",
        "approval_date": "Oct 20, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Nov 16, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELTROMBOPAG OLAMINE",
  "proprietary_name": "PROMACTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022291",
  "marketing_category": "NDA",
  "nonproprietary_name": "eltrombopag olamine",
  "start_marketing_date": "20160524",
  "active_numerator_strength": "25"
}