{
  "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": "13",
          "submission_status": "AP",
          "submission_status_date": "20160229",
          "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": "20090715",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "15821",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf",
              "date": "20090716",
              "type": "Label"
            },
            {
              "id": "28175",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021583s011ltr.pdf",
              "date": "20090717",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20071005",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021583s006ltr.pdf",
              "date": "20071010",
              "type": "Letter"
            },
            {
              "id": "15820",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf",
              "date": "20071010",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20041217",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "42218",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021583s000TOC.html",
              "date": "20070509",
              "type": "Review"
            },
            {
              "id": "15818",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf",
              "date": "20041230",
              "type": "Label"
            },
            {
              "id": "28173",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021583ltr.pdf",
              "date": "20041230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20201204",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65519",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021583Orig1s033, s034ltr.pdf",
              "date": "20201208",
              "type": "Letter"
            },
            {
              "id": "65577",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf",
              "date": "20201211",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20150123",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5782",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf",
              "date": "20150126",
              "type": "Letter"
            },
            {
              "id": "15823",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf",
              "date": "20150129",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20240711",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79063",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021583Orig1s040ltr.pdf",
              "date": "20240715",
              "type": "Letter"
            },
            {
              "id": "79082",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021583s040lbl.pdf",
              "date": "20240715",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20161014",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45557",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s032ltr.pdf",
              "date": "20161019",
              "type": "Letter"
            },
            {
              "id": "45621",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf",
              "date": "20161017",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20191223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61453",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf",
              "date": "20191226",
              "type": "Letter"
            },
            {
              "id": "61488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf",
              "date": "20191231",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20191223",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61452",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf",
              "date": "20191226",
              "type": "Letter"
            },
            {
              "id": "61489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf",
              "date": "20191231",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20051108",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5779",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s003ltr.pdf",
              "date": "20051118",
              "type": "Letter"
            },
            {
              "id": "15819",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf",
              "date": "20051116",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050502",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28174",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s001ltr.pdf",
              "date": "20050504",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "45",
          "submission_status": "AP",
          "submission_status_date": "20251212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84410",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020246Orig1s074,021583Orig1s045ltr.pdf",
              "date": "20251215",
              "type": "Letter"
            },
            {
              "id": "84449",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020246s074lbl021583s045lbl.pdf#page=28",
              "date": "20251218",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20191223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61454",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf",
              "date": "20191226",
              "type": "Letter"
            },
            {
              "id": "61487",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf",
              "date": "20191231",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20241216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80600",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021583s043lbl.pdf",
              "date": "20241217",
              "type": "Label"
            },
            {
              "id": "80623",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021583Orig1s043ltr.pdf",
              "date": "20241218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20160804",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20201204",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65518",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021583Orig1s033, s034ltr.pdf",
              "date": "20201208",
              "type": "Letter"
            },
            {
              "id": "65578",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf",
              "date": "20201211",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20150130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5781",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021583Orig1s025ltr.pdf",
              "date": "20150202",
              "type": "Letter"
            },
            {
              "id": "15822",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf",
              "date": "20150203",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20180301",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021583s17ltr.pdf",
              "date": "20180302",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20161216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "46288",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf",
              "date": "20161220",
              "type": "Label"
            },
            {
              "id": "46471",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s031ltr.pdf",
              "date": "20161222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20170131",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47082",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021583Orig1s023ltr.pdf",
              "date": "20170201",
              "type": "Letter"
            },
            {
              "id": "47088",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021583s023lbl.pdf",
              "date": "20170201",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021583",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA021583"
        ],
        "brand_name": [
          "DEPO-SUBQ PROVERA"
        ],
        "generic_name": [
          "MEDROXYPROGESTERONE ACETATE"
        ],
        "manufacturer_name": [
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "0009-4709"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "MEDROXYPROGESTERONE ACETATE"
        ],
        "rxcui": [
          "1000156",
          "1000158"
        ],
        "spl_id": [
          "641b0fea-8376-4405-aea2-ac972c4a65eb"
        ],
        "spl_set_id": [
          "390087a6-f3c3-4f0b-a930-79acf412f153"
        ],
        "package_ndc": [
          "0009-4709-13"
        ],
        "unii": [
          "C2QI4IOI2G"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DEPO-SUBQ PROVERA 104",
          "active_ingredients": [
            {
              "name": "MEDROXYPROGESTERONE ACETATE",
              "strength": "104MG/0.65ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}