{
  "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": "79",
          "submission_status": "AP",
          "submission_status_date": "20020522",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "85",
          "submission_status": "AP",
          "submission_status_date": "20090407",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10777",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf",
              "date": "20090416",
              "type": "Label"
            },
            {
              "id": "11957",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf",
              "date": "20090416",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19590527",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2",
          "submission_class_code_description": "Type 2 - New Active Ingredient"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "124",
          "submission_status": "AP",
          "submission_status_date": "20251104",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84067",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/011757Orig1s124ltr.pdf",
              "date": "20251105",
              "type": "Letter"
            },
            {
              "id": "84123",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/011757s124lbl.pdf",
              "date": "20251107",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "75",
          "submission_status": "AP",
          "submission_status_date": "19950124",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "114",
          "submission_status": "AP",
          "submission_status_date": "20180724",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54964",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011757s114lbl.pdf",
              "date": "20180725",
              "type": "Label"
            },
            {
              "id": "54997",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011757Orig1s114Ltr.pdf",
              "date": "20180726",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "59",
          "submission_status": "AP",
          "submission_status_date": "19890105",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "120",
          "submission_status": "AP",
          "submission_status_date": "20210527",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/09866Orig1s115; 11856Orig1s136; 11757Origs120ltr.pdf",
              "date": "20210528",
              "type": "Letter"
            },
            {
              "id": "67702",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s120lbl.pdf",
              "date": "20210604",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "19830309",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "104",
          "submission_status": "AP",
          "submission_status_date": "20160908",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45251",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011757Orig1s104ltr.pdf",
              "date": "20160909",
              "type": "Letter"
            },
            {
              "id": "45261",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011757s104lbl.pdf",
              "date": "20160909",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "63",
          "submission_status": "AP",
          "submission_status_date": "19891214",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "19860512",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "102",
          "submission_status": "AP",
          "submission_status_date": "20140609",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "19860512",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "98",
          "submission_status": "AP",
          "submission_status_date": "20131011",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "86",
          "submission_status": "AP",
          "submission_status_date": "20090407",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11958",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011757s085,s086ltr.pdf",
              "date": "20090416",
              "type": "Letter"
            },
            {
              "id": "33055",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011757s085s086lbl.pdf",
              "date": "20090416",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "119",
          "submission_status": "AP",
          "submission_status_date": "20210211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011757Orig1s119ltr.pdf",
              "date": "20210216",
              "type": "Letter"
            },
            {
              "id": "66223",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011757s119lbl.pdf",
              "date": "20210216",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "78",
          "submission_status": "AP",
          "submission_status_date": "20000404",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "125",
          "submission_status": "AP",
          "submission_status_date": "20240605",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011757s125lbl.pdf",
              "date": "20240606",
              "type": "Label"
            },
            {
              "id": "78707",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/011757Orig1s125ltr.pdf",
              "date": "20240607",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "123",
          "submission_status": "AP",
          "submission_status_date": "20231220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77104",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011757s123lbl.pdf",
              "date": "20231221",
              "type": "Label"
            },
            {
              "id": "77122",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011757Orig1s123ltr.pdf",
              "date": "20231222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "19830309",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "72",
          "submission_status": "AP",
          "submission_status_date": "19940107",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "64",
          "submission_status": "AP",
          "submission_status_date": "19901115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "111",
          "submission_status": "AP",
          "submission_status_date": "20170315",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47598",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011757Orig1s111ltr.pdf",
              "date": "20170320",
              "type": "Letter"
            },
            {
              "id": "64124",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011757Orig1s111lbl.pdf",
              "date": "20200729",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "70",
          "submission_status": "AP",
          "submission_status_date": "19931228",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "103",
          "submission_status": "AP",
          "submission_status_date": "20140703",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "285",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011757Orig1s103ltr.pdf",
              "date": "20140708",
              "type": "Letter"
            },
            {
              "id": "10778",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011757s103lbl.pdf",
              "date": "20140709",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "54",
          "submission_status": "AP",
          "submission_status_date": "19800729",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "60",
          "submission_status": "AP",
          "submission_status_date": "19860512",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "52",
          "submission_status": "AP",
          "submission_status_date": "19780712",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "97",
          "submission_status": "AP",
          "submission_status_date": "20131007",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "19810217",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA011757",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA011757"
        ],
        "brand_name": [
          "DEPO-MEDROL"
        ],
        "generic_name": [
          "METHYLPREDNISOLONE ACETATE"
        ],
        "manufacturer_name": [
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "0009-0274",
          "0009-0280",
          "0009-0306",
          "0009-3073",
          "0009-3475"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRALESIONAL",
          "INTRAMUSCULAR",
          "INTRASYNOVIAL",
          "SOFT TISSUE",
          "INTRA-ARTICULAR"
        ],
        "substance_name": [
          "METHYLPREDNISOLONE ACETATE"
        ],
        "rxcui": [
          "1358510",
          "1358512",
          "1358610",
          "1358612",
          "1358617",
          "1358619",
          "1743779",
          "1743781",
          "1743855",
          "1743856"
        ],
        "spl_id": [
          "267dd735-f800-4735-ba1c-d39d00f0cee5",
          "e4917f75-3e1c-4f3c-803d-d9ec65df06c7",
          "742fcec7-8db3-4cc6-b276-42587a993810"
        ],
        "spl_set_id": [
          "823b0010-2b57-4e76-b5ac-4a8c2963438f",
          "bf1b104d-85cb-414d-a366-78068c82c883",
          "9a7b3837-e038-48bf-97e9-78ad463760dc"
        ],
        "package_ndc": [
          "0009-0274-01",
          "0009-0280-02",
          "0009-0280-51",
          "0009-0280-03",
          "0009-0280-52",
          "0009-0306-02",
          "0009-0306-12",
          "0009-3073-22",
          "0009-3073-23",
          "0009-3475-22",
          "0009-3475-23",
          "0009-3073-01",
          "0009-3073-03",
          "0009-3475-01",
          "0009-3475-03"
        ],
        "unii": [
          "43502P7F0P"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DEPO-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE ACETATE",
              "strength": "40MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "DEPO-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE ACETATE",
              "strength": "80MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "DEPO-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE ACETATE",
              "strength": "20MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}