Delestrogen

{
  "unii": {
    "unii": "OKG364O896",
    "rxcui": "24395",
    "inchikey": "RSEPBGGWRJCQGY-RBRWEJTLSA-N",
    "display_name": "ESTRADIOL VALERATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "e8f94df9-0692-4462-a7f0-fe019a0a3f07": {
      "match": "brand_token",
      "title": "DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "29",
      "published_date": "2026-05-20"
    }
  },
  "productid": "42023-111_58569bae-90e9-492c-a026-9a7b8797b3b4",
  "productndc": "42023-111",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "009402",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AO",
        "strength": "10MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AO",
        "strength": "20MG/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL VALERATE",
  "proprietary_name": "Delestrogen",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA009402",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol valerate",
  "start_marketing_date": "20071101",
  "active_numerator_strength": "20"
}