{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20230410",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73971",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205433Orig1s008ltr.pdf",
              "date": "20230411",
              "type": "Letter"
            },
            {
              "id": "73984",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s008lbl.pdf",
              "date": "20230412",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20141202",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "19644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf",
              "date": "20141203",
              "type": "Label"
            },
            {
              "id": "22987",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205433Orig1s000TOC.html",
              "date": "20150406",
              "type": "Review"
            },
            {
              "id": "32671",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf",
              "date": "20141203",
              "type": "Letter"
            },
            {
              "id": "32672",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf",
              "date": "20140827",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20230210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73466",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205433Orig1s007ltr.pdf",
              "date": "20230213",
              "type": "Letter"
            },
            {
              "id": "73476",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205433s007lbl.pdf",
              "date": "20230213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20191206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61200",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205433s005lbl.pdf",
              "date": "20191209",
              "type": "Label"
            },
            {
              "id": "61206",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205433Orig1s005ltr.pdf",
              "date": "20191210",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20161118",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA205433",
      "sponsor_name": "PULMOFLOW INC",
      "openfda": {
        "application_number": [
          "NDA205433"
        ],
        "brand_name": [
          "TOBRAMYCIN INHALATION SOLUTION PAK",
          "KITABIS PAK"
        ],
        "generic_name": [
          "TOBRAMYCIN"
        ],
        "manufacturer_name": [
          "Genericus, Inc.",
          "Pari Respiratory Equipment, Inc."
        ],
        "product_ndc": [
          "70644-899",
          "24492-850"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "TOBRAMYCIN"
        ],
        "rxcui": [
          "348719",
          "1596030"
        ],
        "spl_id": [
          "aeeb7c89-484f-4429-a5d5-0025d19745fd",
          "49aa9935-4371-43a5-a681-f7a5725b1b2b"
        ],
        "spl_set_id": [
          "dad13445-f591-4829-96f9-1598ba03dff8",
          "da1e5afd-d707-4af1-8935-8195ba6d769f"
        ],
        "package_ndc": [
          "70644-899-99",
          "24492-850-56"
        ],
        "nui": [
          "N0000175477",
          "M0000946"
        ],
        "pharm_class_epc": [
          "Aminoglycoside Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Aminoglycosides [CS]"
        ],
        "unii": [
          "VZ8RRZ51VK"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "KITABIS PAK",
          "active_ingredients": [
            {
              "name": "TOBRAMYCIN",
              "strength": "300MG/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INHALATION",
          "marketing_status": "Prescription",
          "te_code": "AN"
        }
      ]
    }
  ]
}