{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230201",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "73365",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213260s000lbl.pdf",
              "date": "20230202",
              "type": "Label"
            },
            {
              "id": "73367",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213260Orig1s000ltr.pdf",
              "date": "20230202",
              "type": "Letter"
            },
            {
              "id": "73512",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/213260Orig1s000TOC.html",
              "date": "20230216",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20240423",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78232",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213260s002lbl.pdf",
              "date": "20240424",
              "type": "Label"
            },
            {
              "id": "78238",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213260Orig1s002ltr.pdf",
              "date": "20240424",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA213260",
      "sponsor_name": "CMP DEV LLC",
      "openfda": {
        "application_number": [
          "NDA213260"
        ],
        "brand_name": [
          "ATORVALIQ"
        ],
        "generic_name": [
          "ATORVALIQ"
        ],
        "manufacturer_name": [
          "CMP Pharma, Inc."
        ],
        "product_ndc": [
          "46287-030"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATORVASTATIN CALCIUM TRIHYDRATE"
        ],
        "rxcui": [
          "2630760"
        ],
        "spl_id": [
          "fb92775a-6d6d-4d62-ab23-045f16ec5895"
        ],
        "spl_set_id": [
          "41fca2d8-7f3f-45b9-8974-81b89accc211"
        ],
        "package_ndc": [
          "46287-030-01"
        ],
        "unii": [
          "48A5M73Z4Q"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ATORVALIQ",
          "active_ingredients": [
            {
              "name": "ATORVASTATIN CALCIUM",
              "strength": "20MG/5ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}