{
  "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": "5144",
          "submission_status": "AP",
          "submission_status_date": "20080613",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5276",
          "submission_status": "AP",
          "submission_status_date": "20231211",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "76771",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103964s5276lbl.pdf",
              "date": "20231212",
              "type": "Label"
            },
            {
              "id": "76772",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103964s5276lbl.pdf#page=37",
              "date": "20231212",
              "type": "Medication Guide"
            },
            {
              "id": "76773",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103964Orig1s5276ltr.pdf",
              "date": "20231212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5000",
          "submission_status": "AP",
          "submission_status_date": "20021203",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9518",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof120302L.htm",
              "date": "20040325",
              "type": "Letter"
            },
            {
              "id": "18711",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof120302LB.htm",
              "date": "20040325",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5039",
          "submission_status": "AP",
          "submission_status_date": "20050225",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39763",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964_5039lbl.pdf",
              "date": "20050225",
              "type": "Label"
            },
            {
              "id": "31746",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964_5039ltr.pdf",
              "date": "20050303",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5037",
          "submission_status": "AP",
          "submission_status_date": "20050513",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103964s5037lbl.pdf",
              "date": "20050520",
              "type": "Label"
            },
            {
              "id": "31745",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5037ltr.pdf",
              "date": "20050520",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5213",
          "submission_status": "AP",
          "submission_status_date": "20110822",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39768",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf",
              "date": "20110824",
              "type": "Label"
            },
            {
              "id": "9527",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf",
              "date": "20110826",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5177",
          "submission_status": "AP",
          "submission_status_date": "20100303",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9525",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5177ltr.pdf",
              "date": "20100331",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5183",
          "submission_status": "AP",
          "submission_status_date": "20110223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18716",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5183lbl.pdf",
              "date": "20110304",
              "type": "Label"
            },
            {
              "id": "31749",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5183ltr.pdf",
              "date": "20110302",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5264",
          "submission_status": "AP",
          "submission_status_date": "20150318",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39771",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103964s5264lbl.pdf",
              "date": "20150319",
              "type": "Label"
            },
            {
              "id": "31754",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103964Orig1s5264ltr.pdf",
              "date": "20150319",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5270",
          "submission_status": "AP",
          "submission_status_date": "20171013",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "50066",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf",
              "date": "20171017",
              "type": "Label"
            },
            {
              "id": "50090",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103964Orig1s5270ltr.pdf",
              "date": "20171018",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5120",
          "submission_status": "AP",
          "submission_status_date": "20070619",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9520",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103964s5120ltr.pdf",
              "date": "20070705",
              "type": "Letter"
            },
            {
              "id": "18713",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103964s5120lbl.pdf",
              "date": "20070705",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5076",
          "submission_status": "AP",
          "submission_status_date": "20051118",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5171",
          "submission_status": "AP",
          "submission_status_date": "20090807",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5163",
          "submission_status": "AP",
          "submission_status_date": "20090420",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39765",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf",
              "date": "20090507",
              "type": "Label"
            },
            {
              "id": "9523",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf",
              "date": "20090508",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5147",
          "submission_status": "AP",
          "submission_status_date": "20090420",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39764",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103964s5147, 103964s5163lbl.pdf",
              "date": "20090507",
              "type": "Label"
            },
            {
              "id": "9522",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103964s5147,103964s5163ltr.pdf",
              "date": "20090508",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5139",
          "submission_status": "AP",
          "submission_status_date": "20080613",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20021016",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "39761",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegihof101602LB.htm",
              "date": "20040325",
              "type": "Label"
            },
            {
              "id": "51543",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21511 ribavirin clinical prea-Dawn.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51544",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/196_103964S5270 peginterferon clinpharm prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51545",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/197_103964S5270 peginterferon statistical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "22766",
              "url": "https://web.archive.org/web/20170113111452/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080721.htm",
              "date": "20040325",
              "type": "Review"
            },
            {
              "id": "31743",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegihof101602L.htm",
              "date": "20040325",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5216",
          "submission_status": "AP",
          "submission_status_date": "20110509",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5275",
          "submission_status": "AP",
          "submission_status_date": "20210324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66871",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103964Orig1s5275ltr.pdf",
              "date": "20210325",
              "type": "Letter"
            },
            {
              "id": "66881",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103964s5275lbl.pdf",
              "date": "20210325",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5133",
          "submission_status": "AP",
          "submission_status_date": "20081031",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9521",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5133ltr.pdf",
              "date": "20081107",
              "type": "Letter"
            },
            {
              "id": "18714",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5133lbl.pdf",
              "date": "20090116",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5186",
          "submission_status": "AP",
          "submission_status_date": "20110809",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5186lbl.pdf",
              "date": "20110811",
              "type": "Label"
            },
            {
              "id": "9526",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf",
              "date": "20110811",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5273",
          "submission_status": "AP",
          "submission_status_date": "20201015",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64928",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103964Orig1s5273ltr.pdf",
              "date": "20201016",
              "type": "Letter"
            },
            {
              "id": "64933",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103964s5273lbl.pdf",
              "date": "20201016",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5036",
          "submission_status": "AP",
          "submission_status_date": "20041221",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18712",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103964_5036lbl.pdf",
              "date": "20050126",
              "type": "Label"
            },
            {
              "id": "31744",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103964_5036ltr.pdf",
              "date": "20050126",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5184",
          "submission_status": "AP",
          "submission_status_date": "20110527",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "18717",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5184lbl.pdf",
              "date": "20110531",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5176",
          "submission_status": "AP",
          "submission_status_date": "20100524",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9524",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103964s5176ltr.pdf",
              "date": "20100629",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5204",
          "submission_status": "AP",
          "submission_status_date": "20110929",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39767",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf",
              "date": "20111004",
              "type": "Label"
            },
            {
              "id": "31750",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103964s5204ltr.pdf",
              "date": "20111005",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5261",
          "submission_status": "AP",
          "submission_status_date": "20140905",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39770",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103964s5261lbl.pdf",
              "date": "20140909",
              "type": "Label"
            },
            {
              "id": "31753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103964Orig1s5261ltr.pdf",
              "date": "20140908",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5016",
          "submission_status": "AP",
          "submission_status_date": "20031031",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5245",
          "submission_status": "AP",
          "submission_status_date": "20130702",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18718",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5245lbl.pdf",
              "date": "20130703",
              "type": "Label"
            },
            {
              "id": "31752",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5245ltr.pdf",
              "date": "20130703",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5154",
          "submission_status": "AP",
          "submission_status_date": "20080918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18715",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103964s5154lbl.pdf",
              "date": "20090116",
              "type": "Label"
            },
            {
              "id": "31748",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103964s5154ltr.pdf",
              "date": "20081002",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5065",
          "submission_status": "AP",
          "submission_status_date": "20050513",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9519",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5065ltr.pdf",
              "date": "20050520",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5241",
          "submission_status": "AP",
          "submission_status_date": "20130516",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103964s5241lbl.pdf",
              "date": "20130521",
              "type": "Label"
            },
            {
              "id": "31751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103964Orig1s5241ltr.pdf",
              "date": "20130521",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5057",
          "submission_status": "AP",
          "submission_status_date": "20050513",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "31747",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103964s5057ltr.pdf",
              "date": "20050520",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA103964",
      "sponsor_name": "Pharmaand GmbH",
      "openfda": {
        "application_number": [
          "BLA103964"
        ],
        "brand_name": [
          "PEGASYS"
        ],
        "generic_name": [
          "PEGINTERFERON ALFA-2A"
        ],
        "manufacturer_name": [
          "pharmaand GmbH"
        ],
        "product_ndc": [
          "82154-0449",
          "82154-0451"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "PEGINTERFERON ALFA-2A"
        ],
        "rxcui": [
          "351270",
          "352297",
          "731326",
          "731328"
        ],
        "spl_id": [
          "3c18e4a2-193f-ef4e-e063-6394a90a56b2"
        ],
        "spl_set_id": [
          "d9290e5b-6d40-2318-e053-2995a90a9916"
        ],
        "package_ndc": [
          "82154-0449-1",
          "82154-0451-4"
        ],
        "nui": [
          "N0000175521",
          "M0025711"
        ],
        "pharm_class_epc": [
          "Interferon alpha [EPC]"
        ],
        "pharm_class_cs": [
          "Interferon-alpha [CS]"
        ],
        "unii": [
          "Q46947FE7K"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "PEGASYS",
          "active_ingredients": [
            {
              "name": "PEGINTERFERON ALFA-2A",
              "strength": "180U/5ML"
            }
          ],
          "dosage_form": "SYRINGE",
          "route": null,
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "PEGASYS",
          "active_ingredients": [
            {
              "name": "PEGINTERFERON ALFA-2A",
              "strength": "180UG/VIAL"
            }
          ],
          "dosage_form": "VIAL",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}