{
  "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": "2026-09-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "116",
          "submission_status": "AP",
          "submission_status_date": "20140404",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "122",
          "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": "67",
          "submission_status": "AP",
          "submission_status_date": "19891002",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "81",
          "submission_status": "AP",
          "submission_status_date": "19940325",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "59",
          "submission_status": "AP",
          "submission_status_date": "19860214",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "73",
          "submission_status": "AP",
          "submission_status_date": "19901207",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "19850328",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "104",
          "submission_status": "AP",
          "submission_status_date": "20111020",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10784",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf",
              "date": "20111025",
              "type": "Label"
            },
            {
              "id": "11969",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf",
              "date": "20111025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "49",
          "submission_status": "AP",
          "submission_status_date": "19811016",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "19890322",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "19800930",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "61",
          "submission_status": "AP",
          "submission_status_date": "19860123",
          "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": "19850227",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "139",
          "submission_status": "AP",
          "submission_status_date": "20211027",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "69419",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s139lbl.pdf",
              "date": "20211129",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "19791113",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "143",
          "submission_status": "AP",
          "submission_status_date": "20251104",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84068",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/011856Orig1s143ltr.pdf",
              "date": "20251105",
              "type": "Letter"
            },
            {
              "id": "84121",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/011856s143lbl.pdf",
              "date": "20251107",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "94",
          "submission_status": "AP",
          "submission_status_date": "20021021",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "127",
          "submission_status": "AP",
          "submission_status_date": "20150806",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "141",
          "submission_status": "AP",
          "submission_status_date": "20231220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77105",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011856s141lbl.pdf",
              "date": "20231221",
              "type": "Label"
            },
            {
              "id": "77123",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011856Orig1s141ltr.pdf",
              "date": "20231222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "119",
          "submission_status": "AP",
          "submission_status_date": "20140328",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "133",
          "submission_status": "AP",
          "submission_status_date": "20180724",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54963",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s133lbl.pdf",
              "date": "20180725",
              "type": "Label"
            },
            {
              "id": "54998",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011856Orig1s133Ltr.pdf",
              "date": "20180726",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "78",
          "submission_status": "AP",
          "submission_status_date": "19931105",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "92",
          "submission_status": "AP",
          "submission_status_date": "19990316",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "84",
          "submission_status": "AP",
          "submission_status_date": "19940406",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "131",
          "submission_status": "AP",
          "submission_status_date": "20180328",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53571",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s131lbl.pdf",
              "date": "20180401",
              "type": "Label"
            },
            {
              "id": "53584",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011856Orig1s131ltr.pdf",
              "date": "20180401",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "123",
          "submission_status": "AP",
          "submission_status_date": "20140703",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11971",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011856Orig1s123ltr.pdf",
              "date": "20140707",
              "type": "Letter"
            },
            {
              "id": "33063",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf",
              "date": "20140709",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "68",
          "submission_status": "AP",
          "submission_status_date": "19890711",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "107",
          "submission_status": "AP",
          "submission_status_date": "20100624",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11970",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/011856s107ltr.pdf",
              "date": "20100628",
              "type": "Letter"
            },
            {
              "id": "33062",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf",
              "date": "20100701",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "121",
          "submission_status": "AP",
          "submission_status_date": "20140722",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "19861208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "72",
          "submission_status": "AP",
          "submission_status_date": "19940422",
          "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": "20111020",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "291",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011856s103,s104ltr.pdf",
              "date": "20111025",
              "type": "Letter"
            },
            {
              "id": "33061",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf",
              "date": "20111025",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "19861208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "54",
          "submission_status": "AP",
          "submission_status_date": "19830503",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "46",
          "submission_status": "AP",
          "submission_status_date": "19800428",
          "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": "19860131",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "19810811",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "144",
          "submission_status": "AP",
          "submission_status_date": "20240605",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78675",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011856s144lbl.pdf",
              "date": "20240606",
              "type": "Label"
            },
            {
              "id": "78708",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/011856Orig1s144ltr.pdf",
              "date": "20240607",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "19810220",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "136",
          "submission_status": "AP",
          "submission_status_date": "20210527",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67628",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/09866Orig1s115; 11856Orig1s136; 11757Origs120ltr.pdf",
              "date": "20210528",
              "type": "Letter"
            },
            {
              "id": "67701",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s136lbl.pdf",
              "date": "20210604",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "87",
          "submission_status": "AP",
          "submission_status_date": "19940915",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "93",
          "submission_status": "AP",
          "submission_status_date": "20000403",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "126",
          "submission_status": "AP",
          "submission_status_date": "20160908",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45250",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf",
              "date": "20160909",
              "type": "Letter"
            },
            {
              "id": "45263",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf",
              "date": "20160909",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19590518",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2",
          "submission_class_code_description": "Type 2 - New Active Ingredient"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "77",
          "submission_status": "AP",
          "submission_status_date": "19910904",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "91",
          "submission_status": "AP",
          "submission_status_date": "19980226",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "124",
          "submission_status": "AP",
          "submission_status_date": "20160908",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45249",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011856Orig1s124,s126ltr.pdf",
              "date": "20160909",
              "type": "Letter"
            },
            {
              "id": "45262",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf",
              "date": "20160909",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "69",
          "submission_status": "AP",
          "submission_status_date": "19900424",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA011856",
      "sponsor_name": "PHARMACIA AND UPJOHN",
      "openfda": {
        "application_number": [
          "NDA011856"
        ],
        "brand_name": [
          "SOLU-MEDROL"
        ],
        "generic_name": [
          "METHYLPREDNISOLONE SODIUM SUCCINATE"
        ],
        "manufacturer_name": [
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "0009-0003",
          "0009-0758",
          "0009-0698",
          "0009-0039",
          "0009-0047",
          "0009-0018",
          "0009-0850"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "METHYLPREDNISOLONE SODIUM SUCCINATE"
        ],
        "rxcui": [
          "207191",
          "207193",
          "311659",
          "314099",
          "1357886",
          "1357888",
          "1743704",
          "1743707",
          "1743720",
          "1743722",
          "1743726",
          "1743729"
        ],
        "spl_id": [
          "c157d266-8633-4c2e-ae1f-0207e4f19b35",
          "9fdbd924-74fd-4b07-882c-d7e11b1a4642"
        ],
        "spl_set_id": [
          "cd99be87-c8d9-48d6-a8e5-e081052e3f19",
          "7271310c-7764-4812-aa30-a5e90987c7a9"
        ],
        "package_ndc": [
          "0009-0758-01",
          "0009-0698-01",
          "0009-0039-30",
          "0009-0039-28",
          "0009-0039-33",
          "0009-0039-32",
          "0009-0047-25",
          "0009-0047-22",
          "0009-0047-27",
          "0009-0047-26",
          "0009-0003-02",
          "0009-0018-20",
          "0009-0850-01",
          "0009-0698-02",
          "0009-0039-05",
          "0009-0039-06",
          "0009-0047-03",
          "0009-0047-04"
        ],
        "unii": [
          "LEC9GKY20K"
        ]
      },
      "products": [
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "SOLU-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
              "strength": "EQ 1GM BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "SOLU-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
              "strength": "EQ 125MG BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "SOLU-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
              "strength": "EQ 2GM BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "SOLU-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
              "strength": "EQ 500MG BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "SOLU-MEDROL",
          "active_ingredients": [
            {
              "name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
              "strength": "EQ 40MG BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}