WIDAPLIK

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a30ff81d-420b-40ea-83d8-670260a93fff": {
      "match": "brand_token",
      "title": "WIDAPLIK (TELMISARTAN, AMLODIPINE AND INDAPAMIDE) TABLET [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-04-20"
    }
  },
  "productid": "24338-002_d5293244-59c5-44b0-b82b-0f1cf863d8fb",
  "productndc": "24338-002",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219423",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.25MG BASE;0.625MG;10MG",
        "product_no": "001",
        "approval_date": "Jun 5, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5MG BASE;1.25MG;20MG",
        "product_no": "002",
        "approval_date": "Jun 5, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE;2.5MG;40MG",
        "product_no": "003",
        "approval_date": "Jun 5, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "WIDAPLIK",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA219423",
  "marketing_category": "NDA",
  "nonproprietary_name": "telmisartan, amlodipine and indapamide",
  "start_marketing_date": "20251020",
  "active_numerator_strength": "2.5; 1.25; 20"
}