{
  "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": "11",
          "submission_status": "AP",
          "submission_status_date": "20140926",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20240228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77655",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022210Orig1s026ltr.pdf",
              "date": "20240229",
              "type": "Letter"
            },
            {
              "id": "77670",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf",
              "date": "20240229",
              "type": "Label"
            },
            {
              "id": "77671",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf#page=14",
              "date": "20240229",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20110610",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "29411",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s008ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20220928",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72804",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf",
              "date": "20221207",
              "type": "Label"
            },
            {
              "id": "72816",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022210Orig1s024CorrectedLtr.pdf",
              "date": "20221207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20110615",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "54071",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210_Pancrelapse_Clinical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "67206",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210s006 Zenpep clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "68847",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210s006 Zenpep clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "17090",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s006ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "29410",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20140325",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "38389",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20130411",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38388",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf",
              "date": "20200323",
              "type": "Label"
            },
            {
              "id": "29412",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20231027",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75984",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022210Orig1s027ltr.pdf",
              "date": "20231030",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20130411",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7054",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "17091",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090827",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 7",
          "submission_class_code_description": "Type 7 - Drug Already Marketed without Approved NDA",
          "application_docs": [
            {
              "id": "44703",
              "title": ".",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210s000sumr.pdf",
              "date": "20200323",
              "type": "Summary Review"
            },
            {
              "id": "51460",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210_Pancrelapse_Statistical_PREA.pdf",
              "date": "20200323",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "53376",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022210_Pancrelipase_Clinpharm_PREA.pdf",
              "date": "20200323",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "53377",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22210 Zenpep clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "67150",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22210s006 Zenpep clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "7053",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022210s000ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "17088",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf",
              "date": "20200323",
              "type": "Label"
            },
            {
              "id": "21958",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210_zenpep_toc.html",
              "date": "20200323",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20161219",
          "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": "20110713",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "17089",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20131209",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20200320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62225",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA022210",
      "sponsor_name": "EURAND PHARMA LTD",
      "openfda": {
        "application_number": [
          "BLA022210"
        ],
        "brand_name": [
          "ZENPEP"
        ],
        "generic_name": [
          "PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE"
        ],
        "manufacturer_name": [
          "Aimmune Therapeutics, Inc."
        ],
        "product_ndc": [
          "73562-110",
          "73562-113",
          "73562-115",
          "73562-111",
          "73562-112",
          "73562-116",
          "73562-114",
          "73562-117"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PANCRELIPASE AMYLASE",
          "PANCRELIPASE LIPASE",
          "PANCRELIPASE PROTEASE"
        ],
        "rxcui": [
          "1594671",
          "1594673",
          "1595290",
          "1595292",
          "1595455",
          "1595457",
          "1595460",
          "1595462",
          "1595471",
          "1595473",
          "1595476",
          "1595478",
          "1995477",
          "1995479",
          "2669470",
          "2669472"
        ],
        "spl_id": [
          "6b24ef38-2c65-4b1d-804a-a8301db084e6"
        ],
        "spl_set_id": [
          "7f16f2d4-8df6-4bd7-ac10-56994fa257b0"
        ],
        "package_ndc": [
          "73562-113-01",
          "73562-113-10",
          "73562-115-01",
          "73562-115-10",
          "73562-110-01",
          "73562-110-10",
          "73562-111-01",
          "73562-112-01",
          "73562-116-01",
          "73562-116-12",
          "73562-114-01",
          "73562-114-12",
          "73562-117-01",
          "73562-117-12"
        ],
        "unii": [
          "YOJ58O116E",
          "8MYC33932O",
          "3560D81V50"
        ]
      },
      "products": [
        {
          "product_number": "007",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "168,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "40,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "126,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "14,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "3,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "10,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "63,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "15,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "47,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "24,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "5,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "17,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "008",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "252,600USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "60,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "189,600USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "006",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "105,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "25,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "79,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "84,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "20,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "63,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "ZENPEP",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "42,000USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "10,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "32,000USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}