{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20150914",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090709"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20200820",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20150914",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA090228",
      "sponsor_name": "INVAGEN PHARMS",
      "openfda": {
        "application_number": [
          "ANDA090228"
        ],
        "brand_name": [
          "FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "CIPLA USA INC."
        ],
        "product_ndc": [
          "69097-972",
          "69097-973"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FOSINOPRIL SODIUM",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "857166",
          "857174"
        ],
        "spl_id": [
          "25e66ad5-947a-4262-a996-a9695601d301"
        ],
        "spl_set_id": [
          "4e1ed7da-029e-48d6-a5e4-fc7ac11192fb"
        ],
        "package_ndc": [
          "69097-972-07",
          "69097-973-07"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "0J48LPH2TH",
          "NW2RTH6T2N"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "FOSINOPRIL SODIUM",
              "strength": "10MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "FOSINOPRIL SODIUM",
              "strength": "20MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}