Welchol

{
  "unii": {
    "unii": "P4SG24WI5Q",
    "rxcui": "141625",
    "inchikey": null,
    "display_name": "COLESEVELAM HYDROCHLORIDE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "89cbd0a3-2d1b-41db-8c97-35ec67b7b09f": {
      "match": "brand_token",
      "title": "WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [COSETTE PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2024-12-04"
    }
  },
  "productid": "0713-0880_285004c5-f33a-aaa1-e063-6394a90aac01",
  "productndc": "0713-0880",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "022362",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Oct 2, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3.75GM/PACKET",
        "product_no": "002",
        "approval_date": "Oct 2, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COLESEVELAM HYDROCHLORIDE",
  "proprietary_name": "Welchol",
  "active_ingred_unit": "g/1",
  "application_number": "NDA022362",
  "marketing_category": "NDA",
  "nonproprietary_name": "colesevelam hydrochloride",
  "start_marketing_date": "20220901",
  "active_numerator_strength": "3.75"
}