{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "19951129",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19590224",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "64",
          "submission_status": "AP",
          "submission_status_date": "20020110",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "56",
          "submission_status": "AP",
          "submission_status_date": "19940216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "19970908",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "60",
          "submission_status": "AP",
          "submission_status_date": "19981105",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "19921028",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "59",
          "submission_status": "AP",
          "submission_status_date": "19960208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "19940926",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "19940629",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "61",
          "submission_status": "AP",
          "submission_status_date": "19970909",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "19921028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "51",
          "submission_status": "AP",
          "submission_status_date": "19921028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "NDA011835",
      "sponsor_name": "MERCK",
      "products": [
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "HYDRODIURIL",
          "active_ingredients": [
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "HYDRODIURIL",
          "active_ingredients": [
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "HYDRODIURIL",
          "active_ingredients": [
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}