{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20021010",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20001103",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19990819",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19971107",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19970314",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "51766",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333_anagrelide-HC1_Agrylin_WR_orig.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "51767",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333_anagrelide-HC1_Agrylin_amend 1.pdf",
              "date": "19000101",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "51768",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333_anagrelide-HC1_Agrylin_amend 2.pdf",
              "date": "19000101",
              "type": "Pediatric Amendment 2"
            },
            {
              "id": "51769",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333s008_anagrelide_Agrylin_MedR.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51770",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020333s008_anagrelide_Agrylin_ClinPharmR.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20200228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "62011",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020333Orig1s026ltr.pdf",
              "date": "20200303",
              "type": "Letter"
            },
            {
              "id": "62018",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020333s026lbl.pdf",
              "date": "20200304",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20180320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53252",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s024lbl.pdf",
              "date": "20180323",
              "type": "Label"
            },
            {
              "id": "53490",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020333Orig1s024ltr.pdf",
              "date": "20180328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20100630",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2346",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020333s016ltr.pdf",
              "date": "20100702",
              "type": "Letter"
            },
            {
              "id": "34515",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf",
              "date": "20100706",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20141030",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "12461",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf",
              "date": "20141104",
              "type": "Label"
            },
            {
              "id": "24794",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s022ltr.pdf",
              "date": "20141103",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20130717",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24793",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020333Orig1s020ltr.pdf",
              "date": "20130719",
              "type": "Letter"
            },
            {
              "id": "34516",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf",
              "date": "20130723",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20041210",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "2344",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf",
              "date": "20041210",
              "type": "Letter"
            },
            {
              "id": "34513",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf",
              "date": "20041210",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20041217",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12457",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf",
              "date": "20041230",
              "type": "Label"
            },
            {
              "id": "2345",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s010ltr.pdf",
              "date": "20041230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20020315",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20000313",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19981216",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "12455",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf",
              "date": "19981216",
              "type": "Label"
            },
            {
              "id": "20598",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20333-S002_Agrylin.pdf",
              "date": "19981216",
              "type": "Review"
            },
            {
              "id": "2343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20333S2ltr.pdf",
              "date": "19981216",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20211013",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68987",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020333Orig1s027ltr.pdf",
              "date": "20211014",
              "type": "Letter"
            },
            {
              "id": "68993",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020333s027lbl.pdf",
              "date": "20211014",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20111122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12460",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf",
              "date": "20111130",
              "type": "Label"
            },
            {
              "id": "2347",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s019ltr.pdf",
              "date": "20111128",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20181219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56899",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s025lbl.pdf",
              "date": "20181220",
              "type": "Label"
            },
            {
              "id": "56949",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020333Orig1s025Ltr.pdf",
              "date": "20181221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20110131",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12459",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf",
              "date": "20110131",
              "type": "Label"
            },
            {
              "id": "24792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s017ltr.pdf",
              "date": "20110204",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20150714",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12462",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf",
              "date": "20150716",
              "type": "Label"
            },
            {
              "id": "24795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020333Orig1s023ltr.pdf",
              "date": "20150715",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20090709",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24791",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020333s015ltr.pdf",
              "date": "20090717",
              "type": "Letter"
            },
            {
              "id": "34514",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf",
              "date": "20090723",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20140207",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2348",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s021ltr.pdf",
              "date": "20140211",
              "type": "Letter"
            },
            {
              "id": "34517",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf",
              "date": "20140210",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20080617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41284",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020333Orig1s013.pdf",
              "date": "20150821",
              "type": "Review"
            },
            {
              "id": "12458",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf",
              "date": "20080619",
              "type": "Label"
            },
            {
              "id": "24790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020333s013ltr.pdf",
              "date": "20080620",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20041210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12456",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf",
              "date": "20041210",
              "type": "Label"
            },
            {
              "id": "24789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf",
              "date": "20041210",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020333",
      "sponsor_name": "TAKEDA PHARMS USA",
      "openfda": {
        "application_number": [
          "NDA020333"
        ],
        "brand_name": [
          "AGRYLIN"
        ],
        "generic_name": [
          "ANAGRELIDE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "54092-063"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ANAGRELIDE HYDROCHLORIDE ANHYDROUS"
        ],
        "rxcui": [
          "597850",
          "597857"
        ],
        "spl_id": [
          "80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd"
        ],
        "spl_set_id": [
          "cb960074-99c1-4a73-941f-f0644a7ec219"
        ],
        "package_ndc": [
          "54092-063-01"
        ],
        "unii": [
          "VNS4435G39"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "AGRYLIN",
          "active_ingredients": [
            {
              "name": "ANAGRELIDE HYDROCHLORIDE",
              "strength": "EQ 0.5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "AGRYLIN",
          "active_ingredients": [
            {
              "name": "ANAGRELIDE HYDROCHLORIDE",
              "strength": "EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}