{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20241216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80601",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020753s025lbl.pdf",
              "date": "20241217",
              "type": "Label"
            },
            {
              "id": "80622",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020753Orig1s025ltr.pdf",
              "date": "20241218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20140728",
          "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": "19991021",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "13341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20753LBL.PDF",
              "date": "19991021",
              "type": "Label"
            },
            {
              "id": "20900",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-753_Aromasin.html",
              "date": "20040527",
              "type": "Review"
            },
            {
              "id": "3262",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20753LTR.PDF",
              "date": "19991021",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20140502",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25704",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016ltr.pdf",
              "date": "20140506",
              "type": "Letter"
            },
            {
              "id": "35273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf",
              "date": "20140506",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20051005",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "13344",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020753s006lbl.pdf",
              "date": "20051007",
              "type": "Label"
            },
            {
              "id": "3264",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020753s006ltr.pdf",
              "date": "20051011",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20110325",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13346",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf",
              "date": "20110328",
              "type": "Label"
            },
            {
              "id": "25703",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf",
              "date": "20110328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20010404",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20160725",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "13350",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020753s018lbl.pdf",
              "date": "20160727",
              "type": "Label"
            },
            {
              "id": "25705",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020753Orig1s018ltr.pdf",
              "date": "20160726",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20110325",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13345",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf",
              "date": "20110328",
              "type": "Label"
            },
            {
              "id": "25702",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf",
              "date": "20110328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20140502",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13349",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf",
              "date": "20140506",
              "type": "Label"
            },
            {
              "id": "3267",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020753Orig1s015,s016ltr.pdf",
              "date": "20140506",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20081224",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24138",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020753s007PatientInfo.pdf",
              "date": "20090102",
              "type": "Patient Information Sheet"
            },
            {
              "id": "25701",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020753s007ltr.pdf",
              "date": "20081230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20211117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69342",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020753Orig1s022ltr.pdf",
              "date": "20211118",
              "type": "Letter"
            },
            {
              "id": "69356",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020753s022lbl.pdf",
              "date": "20211118",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20130215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13348",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020753s014lbl.pdf",
              "date": "20130220",
              "type": "Label"
            },
            {
              "id": "3266",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020753Orig1s014ltr.pdf",
              "date": "20130220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20040923",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20753s005lbl.pdf",
              "date": "20040929",
              "type": "Label"
            },
            {
              "id": "25700",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20753s005ltr.pdf",
              "date": "20040929",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20180518",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54276",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020753Orig1s020ltr.pdf",
              "date": "20180521",
              "type": "Letter"
            },
            {
              "id": "54284",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020753s020lbl.pdf",
              "date": "20180522",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20110325",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13347",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf",
              "date": "20110328",
              "type": "Label"
            },
            {
              "id": "3265",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020753s009,s011s012ltr.pdf",
              "date": "20110328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20031113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "13342",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20753slr003_aromasin_lbl.pdf",
              "date": "20031202",
              "type": "Label"
            },
            {
              "id": "3263",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20753slr003ltr.pdf",
              "date": "20031125",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20010404",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA020753",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA020753"
        ],
        "brand_name": [
          "EXEMESTANE",
          "AROMASIN"
        ],
        "generic_name": [
          "EXEMESTANE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc.",
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "59762-2858",
          "0009-7663"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EXEMESTANE"
        ],
        "rxcui": [
          "310261",
          "261317"
        ],
        "spl_id": [
          "6aeb23c4-3f3f-4966-829c-12e7e6ec91ef",
          "aacc35a2-0e82-4ba7-bec1-297802d4fa44"
        ],
        "spl_set_id": [
          "69abd0ff-b200-4d1a-b14a-80e980a8e781",
          "cf066b7a-032a-416c-8d40-15ba581423e3"
        ],
        "package_ndc": [
          "59762-2858-1",
          "0009-7663-04"
        ],
        "nui": [
          "N0000175563",
          "N0000175080"
        ],
        "pharm_class_epc": [
          "Aromatase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Aromatase Inhibitors [MoA]"
        ],
        "unii": [
          "NY22HMQ4BX"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "AROMASIN",
          "active_ingredients": [
            {
              "name": "EXEMESTANE",
              "strength": "25MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}