PALSONIFY

{
  "unii": {
    "unii": "FZT5Z83JNS",
    "rxcui": null,
    "inchikey": "BPVXAUKYSITSMT-UHFFFAOYSA-N",
    "display_name": "PALTUSOTINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8a6d2ce0-a621-4ee7-983c-977cd948ff4d": {
      "match": "brand_token",
      "title": "PALSONIFY (PALTUSOTINE) TABLET, FILM COATED [CRINETICS PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-10-03"
    }
  },
  "productid": "84015-920_73db4875-9ff1-4eaf-bc83-0e494aada598",
  "productndc": "84015-920",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219070",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Sep 25, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Sep 25, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALTUSOTINE HYDROCHLORIDE",
  "proprietary_name": "PALSONIFY",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219070",
  "marketing_category": "NDA",
  "nonproprietary_name": "PALTUSOTINE",
  "start_marketing_date": "20250925",
  "active_numerator_strength": "20"
}