{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "1048",
          "submission_status": "AP",
          "submission_status_date": "19951124",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5240",
          "submission_status": "AP",
          "submission_status_date": "20180329",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53549",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf",
              "date": "20180329",
              "type": "Label"
            },
            {
              "id": "53577",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103362Orig1s5240ltr.pdf",
              "date": "20180401",
              "type": "Letter"
            },
            {
              "id": "62323",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/103362Orig1s5240.pdf",
              "date": "20180329",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5249",
          "submission_status": "AP",
          "submission_status_date": "20220505",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71006",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103362Orig1s5249ltr.pdf",
              "date": "20220506",
              "type": "Letter"
            },
            {
              "id": "71024",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103362s5249lbl.pdf",
              "date": "20220507",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19910305",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5237",
          "submission_status": "AP",
          "submission_status_date": "20170210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47178",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103362Orig1s5237ltr.pdf",
              "date": "20170210",
              "type": "Letter"
            },
            {
              "id": "47179",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf",
              "date": "20170213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1045",
          "submission_status": "AP",
          "submission_status_date": "19951222",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5012",
          "submission_status": "AP",
          "submission_status_date": "20020314",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1033",
          "submission_status": "AP",
          "submission_status_date": "19950915",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5140",
          "submission_status": "AP",
          "submission_status_date": "20081104",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "BLA103362",
      "sponsor_name": "BERLEX LABS",
      "openfda": {
        "application_number": [
          "BLA103362"
        ],
        "brand_name": [
          "LEUKINE"
        ],
        "generic_name": [
          "SARGRAMOSTIM"
        ],
        "manufacturer_name": [
          "Partner Therapeutics, Inc."
        ],
        "product_ndc": [
          "71837-5843"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "SARGRAMOSTIM"
        ],
        "rxcui": [
          "208083",
          "315199"
        ],
        "spl_id": [
          "4ad3993c-6c7f-4a33-8ead-a912636ff4a1"
        ],
        "spl_set_id": [
          "bb9a3820-f31a-4dd9-bef4-97094c01a398"
        ],
        "package_ndc": [
          "71837-5843-1",
          "71837-5843-5"
        ],
        "nui": [
          "M0024696",
          "M0024695",
          "N0000009451",
          "N0000175666"
        ],
        "pharm_class_cs": [
          "Granulocyte Colony-Stimulating Factor [CS]",
          "Granulocyte-Macrophage Colony-Stimulating Factor [CS]"
        ],
        "pharm_class_pe": [
          "Increased Myeloid Cell Production [PE]"
        ],
        "pharm_class_epc": [
          "Leukocyte Growth Factor [EPC]"
        ],
        "unii": [
          "5TAA004E22"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "LEUKINE",
          "active_ingredients": [
            {
              "name": "SARGRAMOSTIM",
              "strength": "250UG/ML"
            }
          ],
          "dosage_form": "VIAL",
          "route": null,
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "LEUKINE",
          "active_ingredients": [
            {
              "name": "SARGRAMOSTIM",
              "strength": "500UG/ML"
            }
          ],
          "dosage_form": "VIAL",
          "route": null,
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}