{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20081016",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8186",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050753s009ltr.pdf",
              "date": "20081022",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20130926",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18178",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf",
              "date": "20130927",
              "type": "Label"
            },
            {
              "id": "30449",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050753Orig1s011ltr.pdf",
              "date": "20131001",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20050805",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20000518",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980911",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19971222",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "22219",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050753_tobi_toc.html",
              "date": "20100525",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20230210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73461",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050753Orig1s028ltr.pdf",
              "date": "20230213",
              "type": "Letter"
            },
            {
              "id": "73470",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050753s028lbl.pdf",
              "date": "20230213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20151005",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "8187",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050753Orig1s018ltr.pdf",
              "date": "20151006",
              "type": "Letter"
            },
            {
              "id": "18179",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf",
              "date": "20151008",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20140425",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39254",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf",
              "date": "20140429",
              "type": "Label"
            },
            {
              "id": "30450",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050753Orig1s016ltr.pdf",
              "date": "20140429",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20181005",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "55892",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050753Orig1s022ltr.pdf",
              "date": "20181011",
              "type": "Letter"
            },
            {
              "id": "55916",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s022lbl.pdf",
              "date": "20181015",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20010905",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20020321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "30448",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50753s2ltr.pdf",
              "date": "20020321",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20160429",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20150414",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20181220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56962",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050753Orig1s023Ltr.pdf",
              "date": "20181221",
              "type": "Letter"
            },
            {
              "id": "56987",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s023lbl.pdf",
              "date": "20181220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20131024",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA050753",
      "sponsor_name": "VIATRIS",
      "openfda": {
        "application_number": [
          "NDA050753"
        ],
        "brand_name": [
          "TOBI"
        ],
        "generic_name": [
          "TOBRAMYCIN"
        ],
        "manufacturer_name": [
          "Viatris Specialty LLC"
        ],
        "product_ndc": [
          "49502-345"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL",
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "TOBRAMYCIN"
        ],
        "rxcui": [
          "213194",
          "348719"
        ],
        "spl_id": [
          "abdb1d21-5989-4e31-8036-18a82673eaad"
        ],
        "spl_set_id": [
          "6a3c3871-1d3a-44d6-8be3-526b30123ef7"
        ],
        "package_ndc": [
          "49502-345-99",
          "49502-345-73",
          "49502-345-01",
          "49502-345-74"
        ],
        "nui": [
          "N0000175477",
          "M0000946"
        ],
        "pharm_class_epc": [
          "Aminoglycoside Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Aminoglycosides [CS]"
        ],
        "unii": [
          "VZ8RRZ51VK"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "TOBI",
          "active_ingredients": [
            {
              "name": "TOBRAMYCIN",
              "strength": "300MG/5ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INHALATION",
          "marketing_status": "Prescription",
          "te_code": "AN"
        }
      ]
    }
  ]
}