{
  "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": "8",
          "submission_status": "AP",
          "submission_status_date": "20120131",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20070502"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20110316",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20150916",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20200325",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150916",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20251016",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20120120",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20150916",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA077867",
      "sponsor_name": "PIRAMAL CRITICAL",
      "openfda": {
        "application_number": [
          "ANDA077867"
        ],
        "brand_name": [
          "SEVOFLURANE",
          "SOJOURN"
        ],
        "generic_name": [
          "SEVOFLURANE"
        ],
        "manufacturer_name": [
          "Piramal Critical Care Inc"
        ],
        "product_ndc": [
          "66794-022",
          "66794-012",
          "66794-015"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "SEVOFLURANE"
        ],
        "rxcui": [
          "200243",
          "997625"
        ],
        "spl_id": [
          "44f127bd-86a2-1a85-e063-6394a90a1c58",
          "44ded994-d330-0d67-e063-6394a90a92db",
          "404235ad-60f3-7e4a-e063-6394a90a47d9"
        ],
        "spl_set_id": [
          "b23e14d7-9e5b-13f4-e053-2a95a90a0cde",
          "fedfd1db-7e32-44b2-89e9-7bb00ee6810d",
          "3dbab949-6ab7-4040-9c81-314e5bb61d41"
        ],
        "package_ndc": [
          "66794-022-25",
          "66794-012-25",
          "66794-015-25"
        ],
        "nui": [
          "N0000175975",
          "N0000175681"
        ],
        "pharm_class_pe": [
          "General Anesthesia [PE]"
        ],
        "pharm_class_epc": [
          "General Anesthetic [EPC]"
        ],
        "unii": [
          "38LVP0K73A"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SOJOURN",
          "active_ingredients": [
            {
              "name": "SEVOFLURANE",
              "strength": "100%"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "LIQUID",
          "route": "INHALATION",
          "marketing_status": "Prescription",
          "te_code": "AN"
        }
      ]
    }
  ]
}