LOPREEZA

{
  "unii": {
    "unii": "4TI98Z838E",
    "rxcui": "4083",
    "inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
    "display_name": "ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "966ac064-9eb7-4d15-b271-a7880ed1e79a": {
      "match": "brand_token",
      "title": "LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "10",
      "published_date": "2025-01-24"
    }
  },
  "productid": "69238-1610_617a2d78-e850-4965-a23a-b0eacd0541a1",
  "productndc": "69238-1610",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020907",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG;0.5MG",
        "product_no": "001",
        "approval_date": "Nov 18, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Dec 28, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
  "proprietary_name": "LOPREEZA",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020907",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol/norethindrone acetate",
  "start_marketing_date": "20190107",
  "active_numerator_strength": "1; .5"
}