{
  "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": "2026-06-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 43
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20190807",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20211130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20190807",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20211130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180618",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20240614",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20211130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20230710",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA209912",
      "sponsor_name": "GRAVITI PHARMS",
      "openfda": {
        "application_number": [
          "ANDA209912"
        ],
        "brand_name": [
          "ATORVASTATIN CALCIUM"
        ],
        "generic_name": [
          "ATORVASTATIN CALCIUM, FILM COATED"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "16571-136",
          "16571-137",
          "16571-138",
          "16571-139"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATORVASTATIN CALCIUM TRIHYDRATE"
        ],
        "rxcui": [
          "259255",
          "617310",
          "617311",
          "617312"
        ],
        "spl_id": [
          "b94c6347-161c-44f2-8937-34c5098bf755"
        ],
        "spl_set_id": [
          "73cefb0b-1747-4fe0-b252-377f4ed94c6f"
        ],
        "package_ndc": [
          "16571-136-09",
          "16571-136-50",
          "16571-136-10",
          "16571-137-09",
          "16571-137-50",
          "16571-137-10",
          "16571-138-09",
          "16571-138-50",
          "16571-138-10",
          "16571-139-09",
          "16571-139-50",
          "16571-139-10"
        ],
        "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"
        }
      ]
    }
  ]
}