{
  "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": "36",
          "submission_status": "AP",
          "submission_status_date": "20150312",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "51291",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21730 levalbuterol clinpharm prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51292",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21730 levalbuterol clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51293",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21730 levalbuterol statistical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "16274",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf",
              "date": "20150317",
              "type": "Label"
            },
            {
              "id": "28486",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021730Orig1s036ltr.pdf",
              "date": "20150313",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20060915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28484",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s003ltr.pdf",
              "date": "20060920",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20131125",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20130314",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20120730",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37547",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf",
              "date": "20120730",
              "type": "Label"
            },
            {
              "id": "6074",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021730Orig1s024ltr.pdf",
              "date": "20120801",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050311",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "6072",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21730ltr.pdf",
              "date": "20050314",
              "type": "Letter"
            },
            {
              "id": "21795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021730s000TOC.html",
              "date": "20061213",
              "type": "Review"
            },
            {
              "id": "37546",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf",
              "date": "20050314",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20170227",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47370",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021730s039lbl.pdf",
              "date": "20170228",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20080205",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "6073",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021730s008ltr.pdf",
              "date": "20080207",
              "type": "Letter"
            },
            {
              "id": "16272",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf",
              "date": "20080214",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20060404",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28485",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s006ltr.pdf",
              "date": "20060407",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20121207",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20140827",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20130910",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6075",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021730Orig1s033ltr.pdf",
              "date": "20130912",
              "type": "Letter"
            },
            {
              "id": "16273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf",
              "date": "20130911",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20130109",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20160122",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA021730",
      "sponsor_name": "LUPIN",
      "openfda": {
        "application_number": [
          "NDA021730"
        ],
        "brand_name": [
          "XOPENEX HFA",
          "LEVALBUTEROL TARTRATE HFA INHALATION"
        ],
        "generic_name": [
          "LEVALBUTEROL TARTRATE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc.",
          "Actavis Pharma, Inc.",
          "Praxis, LLC"
        ],
        "product_ndc": [
          "27437-056",
          "0591-2927",
          "59368-410"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVALBUTEROL TARTRATE"
        ],
        "rxcui": [
          "745791",
          "746466"
        ],
        "spl_id": [
          "905559df-c984-469d-b6b1-a38fdc320471",
          "f9039b6c-2ae3-416b-bc2a-ab6e06e830bf",
          "37c9bb3a-2206-194d-e063-6394a90a145c"
        ],
        "spl_set_id": [
          "70a35706-d7a8-4a48-98c6-1cab1c42fe8d",
          "ac85703a-17a2-4f0b-87f4-78f1756d2f85",
          "37c9c12a-db54-1fd6-e063-6394a90afb92"
        ],
        "package_ndc": [
          "27437-056-01",
          "0591-2927-54",
          "59368-410-01"
        ],
        "unii": [
          "ADS4I3E22M"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "XOPENEX HFA",
          "active_ingredients": [
            {
              "name": "LEVALBUTEROL TARTRATE",
              "strength": "EQ 0.045MG BASE/INH"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "AEROSOL, METERED",
          "route": "INHALATION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}