{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "48",
          "submission_status": "AP",
          "submission_status_date": "20130325",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41230",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s048.pdf",
              "date": "20140805",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "20201204",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65516",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s060, s062ltr.pdf",
              "date": "20201208",
              "type": "Letter"
            },
            {
              "id": "65571",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf",
              "date": "20201210",
              "type": "Label"
            },
            {
              "id": "77710",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/020246Orig1s060s062.pdf",
              "date": "20240305",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "54",
          "submission_status": "AP",
          "submission_status_date": "20150123",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24656",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf",
              "date": "20150126",
              "type": "Letter"
            },
            {
              "id": "34428",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf",
              "date": "20150129",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "60",
          "submission_status": "AP",
          "submission_status_date": "20201204",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65515",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s060, s062ltr.pdf",
              "date": "20201208",
              "type": "Letter"
            },
            {
              "id": "65572",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf",
              "date": "20201210",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "52",
          "submission_status": "AP",
          "submission_status_date": "20140609",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20555",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/20246Orig1s052.pdf",
              "date": "20140805",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19951128",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20101015",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "2242",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020246s036ltr.pdf",
              "date": "20101019",
              "type": "Letter"
            },
            {
              "id": "34427",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020246s036lbl.pdf",
              "date": "20101019",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "20130927",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20554",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s050.pdf",
              "date": "20140805",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19960201",
          "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": "19941201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20160224",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20020523",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19940217",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20000403",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "19980812",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "20200909",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64541",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s043s057lbl.pdf",
              "date": "20200910",
              "type": "Label"
            },
            {
              "id": "64545",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s043, s057ltr.pdf",
              "date": "20200910",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "49",
          "submission_status": "AP",
          "submission_status_date": "20130910",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20553",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s049.pdf",
              "date": "20140805",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "63",
          "submission_status": "AP",
          "submission_status_date": "20170316",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47591",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020246Orig1s063ltr.pdf",
              "date": "20170320",
              "type": "Letter"
            },
            {
              "id": "77711",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/020246Orig1s060s062.pdf",
              "date": "20240305",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19921029",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "20150130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12372",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s053lbl.pdf",
              "date": "20150203",
              "type": "Label"
            },
            {
              "id": "2243",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s053ltr.pdf",
              "date": "20150202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19960320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20200909",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64539",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s043, s057ltr.pdf",
              "date": "20200910",
              "type": "Letter"
            },
            {
              "id": "64542",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s043s057lbl.pdf",
              "date": "20200910",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19950503",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20110728",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "12371",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020246s035lbl.pdf",
              "date": "20110805",
              "type": "Label"
            },
            {
              "id": "24655",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020246s035ltr.pdf",
              "date": "20110801",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20030523",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "12369",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20246scs019_Depo-provera_lbl.pdf",
              "date": "20030608",
              "type": "Label"
            },
            {
              "id": "2240",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20246scs019ltr.pdf",
              "date": "20030608",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20041117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48863",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020246Orig1s025.pdf",
              "date": "20170629",
              "type": "Review"
            },
            {
              "id": "12370",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20246s025lbl.pdf",
              "date": "20041203",
              "type": "Label"
            },
            {
              "id": "2241",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20246s025ltr.pdf",
              "date": "20041202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19941201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20020426",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20010607",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "68",
          "submission_status": "AP",
          "submission_status_date": "20240711",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79061",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020246Orig1s068ltr.pdf",
              "date": "20240715",
              "type": "Letter"
            },
            {
              "id": "79083",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020246s068lbl.pdf",
              "date": "20240715",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "74",
          "submission_status": "AP",
          "submission_status_date": "20251212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84409",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020246Orig1s074,021583Orig1s045ltr.pdf",
              "date": "20251215",
              "type": "Letter"
            },
            {
              "id": "84448",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020246s074lbl021583s045lbl.pdf",
              "date": "20251218",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20051028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12368",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020246s013lbl.pdf",
              "date": "20051101",
              "type": "Label"
            },
            {
              "id": "24654",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020246s013ltr.pdf",
              "date": "20051101",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "20161216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "46290",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020246s058lbl.pdf",
              "date": "20161220",
              "type": "Label"
            },
            {
              "id": "46451",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020246Orig1s058ltr.pdf",
              "date": "20161221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "19970131",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "NDA020246",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA020246"
        ],
        "brand_name": [
          "MEDROXYPROGESTERONE ACETATE",
          "DEPO-PROVERA"
        ],
        "generic_name": [
          "MEDROXYPROGESTERONE ACETATE"
        ],
        "manufacturer_name": [
          "Prasco Laboratories",
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "66993-370",
          "66993-371",
          "0009-0746",
          "0009-7376"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "MEDROXYPROGESTERONE ACETATE"
        ],
        "rxcui": [
          "1000126",
          "1000153",
          "1000128",
          "1000154"
        ],
        "spl_id": [
          "bb8e3bf5-b546-4384-a08a-aea1fa79f8b7",
          "048d453b-e149-464e-99a9-97b2db8582c9"
        ],
        "spl_set_id": [
          "987496bf-b4b0-409b-b745-f52ed0871f4e",
          "199cf13e-0859-4a73-9b45-e700d0cd1049"
        ],
        "package_ndc": [
          "66993-370-83",
          "66993-370-25",
          "66993-371-79",
          "0009-0746-30",
          "0009-0746-35",
          "0009-7376-11"
        ],
        "unii": [
          "C2QI4IOI2G"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DEPO-PROVERA",
          "active_ingredients": [
            {
              "name": "MEDROXYPROGESTERONE ACETATE",
              "strength": "150MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}