{
  "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": "9",
          "submission_status": "AP",
          "submission_status_date": "20150330",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20160516",
          "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": "20140527",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "17678",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20240228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77656",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022523Orig1s019ltr.pdf",
              "date": "20240229",
              "type": "Letter"
            },
            {
              "id": "77664",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022523s019lbl.pdf",
              "date": "20240229",
              "type": "Label"
            },
            {
              "id": "77665",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022523s019lbl.pdf#page=15",
              "date": "20240229",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20121207",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20200320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62230",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla",
              "date": "20200323",
              "type": "Other"
            },
            {
              "id": "62231",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla",
              "date": "20200323",
              "type": "Other"
            },
            {
              "id": "62263",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022523Orig1s013ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "62347",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf",
              "date": "20200326",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150303",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20140623",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140307",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "63230",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N22523S004-Pancrelipase-Clinical-PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "7497",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf",
              "date": "20200323",
              "type": "Label"
            },
            {
              "id": "17677",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022523Orig1s004ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20110620",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "29826",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022523s002ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20210426",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69216",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022523Orig1s016Corrected_ltr.pdf",
              "date": "20211103",
              "type": "Letter"
            },
            {
              "id": "69221",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf",
              "date": "20211103",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20200128",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "69561",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf",
              "date": "20211215",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160804",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20100412",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 7",
          "submission_class_code_description": "Type 7 - Drug Already Marketed without Approved NDA",
          "application_docs": [
            {
              "id": "42549",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523_pancreaze_toc.html",
              "date": "20200323",
              "type": "Review"
            },
            {
              "id": "51454",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22523 pancrelipase clinical prea.pdf",
              "date": "20200323",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "53367",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022523_pancreaze_statistical_PREA.pdf",
              "date": "20200323",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "63541",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022523_Pancreaze_Clinical_PREA_Pediatric-Review.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63542",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022523_Pancreaze_ClinPharm_PREA_Pediatric_Review.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "63543",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022523_Pancreaze_Statistical_PREA_Pediatric_Review.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "23411",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf",
              "date": "20200323",
              "type": "Label"
            },
            {
              "id": "24331",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523Orig1s000SumR.pdf",
              "date": "20200323",
              "type": "Summary Review"
            },
            {
              "id": "29825",
              "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022523s000ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA022523",
      "sponsor_name": "VIVUS INC",
      "openfda": {
        "application_number": [
          "BLA022523"
        ],
        "brand_name": [
          "PANCREAZE"
        ],
        "generic_name": [
          "PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE"
        ],
        "manufacturer_name": [
          "VIVUS LLC"
        ],
        "product_ndc": [
          "62541-401",
          "62541-402",
          "62541-403",
          "62541-404",
          "62541-405",
          "62541-406"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PANCRELIPASE AMYLASE",
          "PANCRELIPASE LIPASE",
          "PANCRELIPASE PROTEASE"
        ],
        "rxcui": [
          "1806919",
          "1806921",
          "1806924",
          "1806926",
          "1806929",
          "1806931",
          "1806964",
          "1806966",
          "2478453",
          "2478455",
          "2564410",
          "2564412"
        ],
        "spl_id": [
          "36e934b1-3fbb-8f0c-e063-6294a90a968c"
        ],
        "spl_set_id": [
          "e8f5d2fe-728d-42af-99a6-83dddc6539c5"
        ],
        "package_ndc": [
          "62541-402-10",
          "62541-403-10",
          "62541-404-10",
          "62541-405-10",
          "62541-401-10",
          "62541-406-50",
          "62541-406-10"
        ],
        "unii": [
          "YOJ58O116E",
          "8MYC33932O",
          "3560D81V50"
        ]
      },
      "products": [
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "PANCREAZE",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "149,900USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "37,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "97,300USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "PANCREAZE",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "98,400USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "16,800USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "56,800USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "PANCREAZE",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "24,600USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "4,200USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "14,200USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "006",
          "reference_drug": "No",
          "brand_name": "PANCREAZE",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "15,200USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "2,600USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "8,800USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "PANCREAZE",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "83,900USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "21,000USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "54,700USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "PANCREAZE",
          "active_ingredients": [
            {
              "name": "PANCRELIPASE (AMYLASE",
              "strength": "61,500USP UNITS"
            },
            {
              "name": "LIPASE",
              "strength": "10,500USP UNITS"
            },
            {
              "name": "PROTEASE)",
              "strength": "35,500USP UNITS"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}