{
  "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": "9",
          "submission_status": "AP",
          "submission_status_date": "20250211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81223",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204516Orig1s009,s014ltr.pdf",
              "date": "20250212",
              "type": "Letter"
            },
            {
              "id": "81241",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204516s009s014lbl.pdf",
              "date": "20250214",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20230818",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75218",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204516s013lbl.pdf",
              "date": "20230822",
              "type": "Label"
            },
            {
              "id": "75224",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204516Orig1s013ltr.pdf",
              "date": "20230822",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20170428",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48177",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf",
              "date": "20170501",
              "type": "Label"
            },
            {
              "id": "48201",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204516Orig1s005ltr.pdf",
              "date": "20170502",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130628",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "40396",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204516s000lbl.pdf",
              "date": "20130710",
              "type": "Label"
            },
            {
              "id": "43467",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000TOC.html",
              "date": "20140725",
              "type": "Review"
            },
            {
              "id": "44904",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000SumR.pdf",
              "date": "20140725",
              "type": "Summary Review"
            },
            {
              "id": "32566",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204516Orig1s000ltr.pdf",
              "date": "20130702",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20210920",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68676",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204516s011lbl.pdf",
              "date": "20210921",
              "type": "Label"
            },
            {
              "id": "68719",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204516Orig1s011ltr.pdf",
              "date": "20210922",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20141201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "19569",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf",
              "date": "20141203",
              "type": "Label"
            },
            {
              "id": "32567",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204516Orig1s003ltr.pdf",
              "date": "20141202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20131219",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20250211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81224",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204516Orig1s009,s014ltr.pdf",
              "date": "20250212",
              "type": "Letter"
            },
            {
              "id": "81242",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204516s009s014lbl.pdf",
              "date": "20250214",
              "type": "Label"
            },
            {
              "id": "81243",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204516s009s014lbl.pdf#page=22",
              "date": "20250214",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20170104",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "46722",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s004lbl.pdf",
              "date": "20170106",
              "type": "Label"
            },
            {
              "id": "46834",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204516Orig1s004ltr.pdf",
              "date": "20170113",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20140401",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA204516",
      "sponsor_name": "LEGACY PHARMA",
      "openfda": {
        "application_number": [
          "NDA204516"
        ],
        "brand_name": [
          "PAROXETINE",
          "BRISDELLE"
        ],
        "generic_name": [
          "PAROXETINE"
        ],
        "manufacturer_name": [
          "Padagis US LLC",
          "Legacy Pharma USA, Inc."
        ],
        "product_ndc": [
          "0574-0279",
          "83107-027"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PAROXETINE MESYLATE"
        ],
        "rxcui": [
          "1430122",
          "1430128"
        ],
        "spl_id": [
          "2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd",
          "a33eb37f-c69b-41f3-9d18-540bfd226aa6"
        ],
        "spl_set_id": [
          "1383d713-79b9-45bd-bd06-65707f28bc99",
          "502311b3-b617-4cbd-a3ab-a60f2c62880a"
        ],
        "package_ndc": [
          "0574-0279-30",
          "83107-027-30"
        ],
        "unii": [
          "M711N184JE"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BRISDELLE",
          "active_ingredients": [
            {
              "name": "PAROXETINE MESYLATE",
              "strength": "EQ 7.5MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}