{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20250324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81726",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213972s001lbl.pdf",
              "date": "20250325",
              "type": "Label"
            },
            {
              "id": "81729",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213972Orig1s001ltr.pdf",
              "date": "20250325",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20241025",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1/4",
          "submission_class_code_description": "Type 1 - New Molecular Entity and Type 4 - New Combination",
          "application_docs": [
            {
              "id": "79981",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213972s000lbl.pdf",
              "date": "20241025",
              "type": "Label"
            },
            {
              "id": "80012",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213972Orig1s000ltr.pdf",
              "date": "20241028",
              "type": "Letter"
            },
            {
              "id": "80535",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213972Orig1s000TOC.html",
              "date": "20241206",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20251223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84598",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213972Orig1s002ltr.pdf",
              "date": "20251231",
              "type": "Letter"
            },
            {
              "id": "84664",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213972s002lbl.pdf",
              "date": "20260106",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA213972",
      "sponsor_name": "ITERUM THERAP",
      "openfda": {
        "application_number": [
          "NDA213972"
        ],
        "brand_name": [
          "ORLYNVAH"
        ],
        "generic_name": [
          "SULOPENEM ETZADROXIL AND PROBENECID"
        ],
        "manufacturer_name": [
          "ITERUM THERAPEUTICS US LIMITED"
        ],
        "product_ndc": [
          "81153-100"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PROBENECID",
          "SULOPENEM ETZADROXIL"
        ],
        "rxcui": [
          "2717843",
          "2717850"
        ],
        "spl_id": [
          "abcb22dd-7c10-4459-a98c-d03582b426a3"
        ],
        "spl_set_id": [
          "24c451c0-4cfb-37f3-e063-6394a90a895e"
        ],
        "package_ndc": [
          "81153-100-01"
        ],
        "unii": [
          "PO572Z7917",
          "492M3I304T"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ORLYNVAH",
          "active_ingredients": [
            {
              "name": "PROBENECID",
              "strength": "500MG"
            },
            {
              "name": "SULOPENEM ETZADROXIL",
              "strength": "500MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}