{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66543",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210730s001lbl.pdf",
              "date": "20210305",
              "type": "Label"
            },
            {
              "id": "66545",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210730Orig1s001ltr.pdf",
              "date": "20210305",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200807",
          "submission_public_notes": "FR Notice on DEA Scheduling; Date of Approval  October 30, 2020",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "64245",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210730Orig1s000ltr.pdf",
              "date": "20200810",
              "type": "Letter"
            },
            {
              "id": "64247",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210730s000lbl.pdf",
              "date": "20200810",
              "type": "Label"
            },
            {
              "id": "64493",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210730Orig1s000TOC.html",
              "date": "20200904",
              "type": "Review"
            },
            {
              "id": "68935",
              "url": "https://www.federalregister.gov/documents/2020/10/30/2020-22762/schedules-of-controlled-substances-placement-of-oliceridine-in-schedule-ii",
              "date": "20211008",
              "type": "Federal Register Notice"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20251222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84540",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210730Orig1s004ltr.pdf",
              "date": "20251223",
              "type": "Letter"
            },
            {
              "id": "84654",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210730s004lbl.pdf",
              "date": "20260106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20231215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "76971",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210730s002lbl.pdf",
              "date": "20231218",
              "type": "Label"
            },
            {
              "id": "77060",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210730Orig1s002correctedltr.pdf",
              "date": "20231219",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA210730",
      "sponsor_name": "TREVENA",
      "openfda": {
        "application_number": [
          "NDA210730"
        ],
        "brand_name": [
          "OLINVYK"
        ],
        "generic_name": [
          "OLICERIDINE"
        ],
        "manufacturer_name": [
          "Trevena, Inc."
        ],
        "product_ndc": [
          "71308-011",
          "71308-021",
          "71308-301"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "OLICERIDINE"
        ],
        "rxcui": [
          "2392234",
          "2392239",
          "2392242",
          "2392243",
          "2392244",
          "2392245"
        ],
        "spl_id": [
          "43ecba1a-fa95-40e0-a383-8f9cdb6ad6b6"
        ],
        "spl_set_id": [
          "ce167984-8b9d-40b7-84ce-d0f33fff1eaa"
        ],
        "package_ndc": [
          "71308-011-01",
          "71308-011-10",
          "71308-021-01",
          "71308-021-10",
          "71308-301-01",
          "71308-301-10"
        ],
        "unii": [
          "MCN858TCP0"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "OLINVYK",
          "active_ingredients": [
            {
              "name": "OLICERIDINE",
              "strength": "30MG/30ML (1MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OLINVYK",
          "active_ingredients": [
            {
              "name": "OLICERIDINE",
              "strength": "1MG/ML (1MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "OLINVYK",
          "active_ingredients": [
            {
              "name": "OLICERIDINE",
              "strength": "2MG/2ML (1MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}