{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170203",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20241104",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20240722",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA205955",
      "sponsor_name": "SAWAI USA",
      "openfda": {
        "application_number": [
          "ANDA205955"
        ],
        "brand_name": [
          "PITAVASTATIN"
        ],
        "generic_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Upsher-Smith Laboratories, LLC"
        ],
        "product_ndc": [
          "0832-6048",
          "0832-6049",
          "0832-6050"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "rxcui": [
          "861643",
          "861648",
          "861652"
        ],
        "spl_id": [
          "266944ba-7e94-48c6-e063-6394a90adc2e"
        ],
        "spl_set_id": [
          "9ad1ecb9-822d-47c1-9f6f-6f771fa0f924"
        ],
        "package_ndc": [
          "0832-6049-90",
          "0832-6048-90",
          "0832-6050-90"
        ],
        "unii": [
          "IYD54XEG3W"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "PITAVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "PITAVASTATIN CALCIUM",
              "strength": "EQ 1MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "PITAVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "PITAVASTATIN CALCIUM",
              "strength": "EQ 2MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "PITAVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "PITAVASTATIN CALCIUM",
              "strength": "EQ 4MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}