{
  "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": "20240122",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA214513",
      "sponsor_name": "LAURUS",
      "openfda": {
        "application_number": [
          "ANDA214513"
        ],
        "brand_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "generic_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Laurus Labs Limited"
        ],
        "product_ndc": [
          "42385-940",
          "42385-941",
          "42385-942",
          "42385-943"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATORVASTATIN CALCIUM TRIHYDRATE"
        ],
        "rxcui": [
          "259255",
          "617310",
          "617311",
          "617312"
        ],
        "spl_id": [
          "ba8208d7-c3b8-4ddc-8826-9f5265513bfa"
        ],
        "spl_set_id": [
          "9f8ca507-b784-4d18-8d3e-d7d68072c416"
        ],
        "package_ndc": [
          "42385-940-30",
          "42385-940-90",
          "42385-940-01",
          "42385-940-05",
          "42385-940-11",
          "42385-940-10",
          "42385-940-68",
          "42385-941-30",
          "42385-941-90",
          "42385-941-01",
          "42385-941-05",
          "42385-941-11",
          "42385-941-10",
          "42385-941-68",
          "42385-942-30",
          "42385-942-90",
          "42385-942-01",
          "42385-942-05",
          "42385-942-11",
          "42385-942-10",
          "42385-942-68",
          "42385-943-30",
          "42385-943-90",
          "42385-943-01",
          "42385-943-05",
          "42385-943-11",
          "42385-943-08",
          "42385-943-64",
          "42385-943-10",
          "42385-943-68"
        ],
        "unii": [
          "48A5M73Z4Q"
        ]
      },
      "products": [
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "ATORVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "ATORVASTATIN CALCIUM",
              "strength": "EQ 80MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "ATORVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "ATORVASTATIN CALCIUM",
              "strength": "EQ 20MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "ATORVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "ATORVASTATIN CALCIUM",
              "strength": "EQ 40MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ATORVASTATIN CALCIUM",
          "active_ingredients": [
            {
              "name": "ATORVASTATIN CALCIUM",
              "strength": "EQ 10MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}