{
  "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": "5",
          "submission_status": "AP",
          "submission_status_date": "20250610",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82532",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205555s005lbl.pdf",
              "date": "20250611",
              "type": "Label"
            },
            {
              "id": "82543",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/205555Orig1s005ltr.pdf",
              "date": "20250612",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170501",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48236",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205555s000lbl.pdf",
              "date": "20170504",
              "type": "Label"
            },
            {
              "id": "48284",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205555Orig1s000ltr.pdf",
              "date": "20170508",
              "type": "Letter"
            },
            {
              "id": "49867",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205555Orig1s000TOC.html",
              "date": "20170927",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA205555",
      "sponsor_name": "NOVATECH SA",
      "openfda": {
        "application_number": [
          "NDA205555"
        ],
        "brand_name": [
          "STERITALC 2G",
          "STERITALC 3G",
          "STERITALC 4G"
        ],
        "generic_name": [
          "TALC"
        ],
        "manufacturer_name": [
          "Novatech SA"
        ],
        "product_ndc": [
          "62327-222",
          "62327-444",
          "62327-333"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAPLEURAL"
        ],
        "substance_name": [
          "TALC"
        ],
        "rxcui": [
          "2003393",
          "2003398",
          "2003400",
          "2003402",
          "2003403",
          "2003405"
        ],
        "spl_id": [
          "386130d4-1b0d-5e87-e063-6394a90aefa7"
        ],
        "spl_set_id": [
          "c94e51d9-beef-4b06-e053-2a95a90a754a"
        ],
        "package_ndc": [
          "62327-444-04",
          "62327-444-44",
          "62327-222-02",
          "62327-222-42",
          "62327-333-03",
          "62327-333-43"
        ],
        "unii": [
          "7SEV7J4R1U"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "STERITALC",
          "active_ingredients": [
            {
              "name": "TALC",
              "strength": "4GM/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "POWDER",
          "route": "INTRAPLEURAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "STERITALC",
          "active_ingredients": [
            {
              "name": "TALC",
              "strength": "2GM/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "POWDER",
          "route": "INTRAPLEURAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "STERITALC",
          "active_ingredients": [
            {
              "name": "TALC",
              "strength": "3GM/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "POWDER",
          "route": "INTRAPLEURAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}