{
  "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": "20011206",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20111216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "3603",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf",
              "date": "20111221",
              "type": "Letter"
            },
            {
              "id": "35527",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf",
              "date": "20111220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20001211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-007.pdf",
              "date": "20040421",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20001211",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41765",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-005.pdf",
              "date": "20040421",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19991116",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "26077",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF",
              "date": "19991230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980629",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "3602",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf",
              "date": "19980629",
              "type": "Letter"
            },
            {
              "id": "41763",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.html",
              "date": "19990408",
              "type": "Review"
            },
            {
              "id": "44077",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm",
              "date": "20031212",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "63548",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864---20865-Rizatriptan-Clinical-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63549",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-Clinical-1-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63550",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-Clinpharm-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "63551",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-CTDL-Addendum-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "63552",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-CTDL-Clinical-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "63553",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-DD-Memo-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric DD Summary Review"
            },
            {
              "id": "63554",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-Statistical-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "63555",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864-and-20865-Rizatriptan-Statistical-2-BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "64070",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864_20865_rizatriptan_Original_WR.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "64071",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20864_20865_rizatriptan_Amendment_1.pdf",
              "date": "19000101",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "13638",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf",
              "date": "19980629",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20111216",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "13640",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf",
              "date": "20111220",
              "type": "Label"
            },
            {
              "id": "26080",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf",
              "date": "20111221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20111216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "3605",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf",
              "date": "20111221",
              "type": "Letter"
            },
            {
              "id": "35529",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf",
              "date": "20111220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20140529",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20020422",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "21029",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020864_s008_MAXALT_TABLETS.pdf",
              "date": "20080801",
              "type": "Review"
            },
            {
              "id": "26078",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf",
              "date": "20020422",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20010125",
          "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": "20001211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "21028",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf",
              "date": "20040415",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20000621",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41764",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf",
              "date": "20040415",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20111216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "3606",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf",
              "date": "20111221",
              "type": "Letter"
            },
            {
              "id": "35530",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf",
              "date": "20111220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20111216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13639",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf",
              "date": "20111220",
              "type": "Label"
            },
            {
              "id": "26079",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf",
              "date": "20111221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20191001",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60193",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf",
              "date": "20191002",
              "type": "Label"
            },
            {
              "id": "60194",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020864Orig1s023, 020865Orig1s024ltr.pdf",
              "date": "20191002",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20150615",
          "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": "20100812",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "35528",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020864s013lbl.pdf",
              "date": "20100819",
              "type": "Label"
            },
            {
              "id": "3604",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020864s013ltr.pdf",
              "date": "20100816",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020864",
      "sponsor_name": "ORGANON LLC",
      "openfda": {
        "application_number": [
          "NDA020864"
        ],
        "brand_name": [
          "MAXALT"
        ],
        "generic_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "manufacturer_name": [
          "Organon LLC"
        ],
        "product_ndc": [
          "78206-142",
          "78206-143"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "rxcui": [
          "213322",
          "312837",
          "314209",
          "828537"
        ],
        "spl_id": [
          "47257235-a46d-4fee-a29d-08f8ba8e46c2"
        ],
        "spl_set_id": [
          "007b4644-e0e7-4863-9ae3-fe09676b3f5f"
        ],
        "package_ndc": [
          "78206-142-99",
          "78206-142-01",
          "78206-143-99",
          "78206-143-01"
        ],
        "unii": [
          "WR978S7QHH"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "MAXALT",
          "active_ingredients": [
            {
              "name": "RIZATRIPTAN BENZOATE",
              "strength": "EQ 10MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "MAXALT",
          "active_ingredients": [
            {
              "name": "RIZATRIPTAN BENZOATE",
              "strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}