{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20201029",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "65083",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s003lbl.pdf",
              "date": "20201030",
              "type": "Label"
            },
            {
              "id": "65118",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208587Orig1s003ltr.pdf",
              "date": "20201102",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191101",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "60783",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208587Orig1s001ltr.pdf",
              "date": "20191105",
              "type": "Letter"
            },
            {
              "id": "60786",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208587s001lbl.pdf",
              "date": "20191106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20250618",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82608",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208587s004lbl.pdf",
              "date": "20250620",
              "type": "Label"
            },
            {
              "id": "82617",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208587Orig1s004ltr.pdf",
              "date": "20250620",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20200422",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "62647",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s002lbl.pdf",
              "date": "20200423",
              "type": "Label"
            },
            {
              "id": "62654",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208587Orig1s002ltr.pdf",
              "date": "20200423",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170707",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48926",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208587s000lbl.pdf",
              "date": "20170707",
              "type": "Label"
            },
            {
              "id": "48945",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208587Orig1s000ltr.pdf",
              "date": "20170711",
              "type": "Letter"
            },
            {
              "id": "53646",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208587Orig1s000TOC.html",
              "date": "20180410",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA208587",
      "sponsor_name": "EMMAUS MEDCL",
      "openfda": {
        "application_number": [
          "NDA208587"
        ],
        "brand_name": [
          "ENDARI"
        ],
        "generic_name": [
          "GLUTAMINE"
        ],
        "manufacturer_name": [
          "Emmaus Medical, Inc."
        ],
        "product_ndc": [
          "42457-420"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GLUTAMINE"
        ],
        "rxcui": [
          "1869684",
          "1928941"
        ],
        "spl_id": [
          "10f5d160-6687-44d5-a607-6bf69a7312b6"
        ],
        "spl_set_id": [
          "d5a783f4-12ef-4326-8faa-40018e45ba3b"
        ],
        "package_ndc": [
          "42457-420-01",
          "42457-420-60"
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "0RH81L854J"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ENDARI",
          "active_ingredients": [
            {
              "name": "L-GLUTAMINE",
              "strength": "5GM/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}