{
  "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": "10",
          "submission_status": "AP",
          "submission_status_date": "20210616",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67836",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021479s010lbl.pdf",
              "date": "20210617",
              "type": "Label"
            },
            {
              "id": "67838",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021479Orig1s010ltr.pdf",
              "date": "20210617",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060614",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "15564",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf",
              "date": "20060620",
              "type": "Label"
            },
            {
              "id": "21684",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.html",
              "date": "20090115",
              "type": "Review"
            },
            {
              "id": "27896",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021479s000LTR.pdf",
              "date": "20060620",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20151009",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20140731",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5497",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021479Orig1s005ltr.pdf",
              "date": "20140801",
              "type": "Letter"
            },
            {
              "id": "15566",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf",
              "date": "20140819",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20081231",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5496",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf",
              "date": "20090106",
              "type": "Letter"
            },
            {
              "id": "15565",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf",
              "date": "20090106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20190819",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021479Orig1s008ltr.pdf",
              "date": "20190820",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20081231",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37035",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf",
              "date": "20090106",
              "type": "Label"
            },
            {
              "id": "27897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf",
              "date": "20090106",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021479",
      "sponsor_name": "BAUSCH",
      "openfda": {
        "application_number": [
          "NDA021479"
        ],
        "brand_name": [
          "ZELAPAR"
        ],
        "generic_name": [
          "SELEGILINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Bausch Health US, LLC"
        ],
        "product_ndc": [
          "0187-0453"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SELEGILINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "859190",
          "859192"
        ],
        "spl_id": [
          "f8d8f532-d8a6-4eff-baab-325fed820cdb"
        ],
        "spl_set_id": [
          "380d7717-2a79-42f3-a712-efe5e7696ba0"
        ],
        "package_ndc": [
          "0187-0453-02",
          "0187-0453-03"
        ],
        "unii": [
          "6W731X367Q"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZELAPAR",
          "active_ingredients": [
            {
              "name": "SELEGILINE HYDROCHLORIDE",
              "strength": "1.25MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET, ORALLY DISINTEGRATING",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}