Cobenfy

{
  "unii": {
    "unii": "1E6682427E",
    "rxcui": "38891",
    "inchikey": "RVCSYOQWLPPAOA-QKYUOBHYSA-M",
    "display_name": "TROSPIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8f0e73bf-6025-44f6-ab64-0983322de0df": {
      "match": "brand_token",
      "title": "COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) CAPSULE, COATED PELLETS COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) KIT [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "4",
      "published_date": "2026-01-30"
    }
  },
  "productid": "0003-1100_51277f95-1b88-42b7-9e2b-7a0bfd609ccf",
  "productndc": "0003-1100",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "216158",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG;EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Sep 26, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG;EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Sep 26, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG;EQ 125MG BASE",
        "product_no": "003",
        "approval_date": "Sep 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TROSPIUM CHLORIDE; XANOMELINE",
  "proprietary_name": "Cobenfy",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA216158",
  "marketing_category": "NDA",
  "nonproprietary_name": "xanomeline and trospium chloride",
  "start_marketing_date": "20240927",
  "active_numerator_strength": "20; 100"
}