{
  "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": "20160708",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150521",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "19641",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205388s001lbl.pdf",
              "date": "20160624",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20140530",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "application_docs": [
            {
              "id": "19640",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205388s000lbl.pdf",
              "date": "20140603",
              "type": "Label"
            },
            {
              "id": "22986",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000TOC.html",
              "date": "20141209",
              "type": "Review"
            },
            {
              "id": "24493",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000SumR.pdf",
              "date": "20141209",
              "type": "Summary Review"
            },
            {
              "id": "32666",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205388Orig1s000ltr.pdf",
              "date": "20140603",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20171208",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "50654",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205388s006lbl.pdf",
              "date": "20171211",
              "type": "Label"
            },
            {
              "id": "50778",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205388Orig1s006ltr.pdf",
              "date": "20171220",
              "type": "Letter"
            },
            {
              "id": "51553",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/213_205388S6 phenylephrine and ketorolac CDTL clinical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "51554",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/214_205388S6 phenylephrine and ketorolac clinical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51555",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/215_205388S6 phenylephrine and ketorolac statistical bpca.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20161027",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20160115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA205388",
      "sponsor_name": "RAYNER SURGICAL",
      "openfda": {
        "application_number": [
          "NDA205388"
        ],
        "brand_name": [
          "OMIDRIA"
        ],
        "generic_name": [
          "PHENYLEPHRINE AND KETOROLAC"
        ],
        "manufacturer_name": [
          "Omeros Corporation",
          "Rayner Surgical Inc."
        ],
        "product_ndc": [
          "62225-600",
          "82604-600"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAOCULAR"
        ],
        "substance_name": [
          "KETOROLAC",
          "PHENYLEPHRINE"
        ],
        "rxcui": [
          "1540230",
          "1540235"
        ],
        "spl_id": [
          "4ef3b158-3042-6a1f-e063-6394a90a807f",
          "ffe62883-85a4-6e94-e053-6294a90ac61f"
        ],
        "spl_set_id": [
          "21470688-4e81-4ea5-ac38-f72e10552e7e",
          "f25d7a42-da2a-7310-e053-2995a90a590f"
        ],
        "package_ndc": [
          "62225-600-00",
          "62225-600-04",
          "62225-600-10",
          "62225-600-99",
          "82604-600-00",
          "82604-600-04",
          "82604-600-99"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722",
          "N0000175939",
          "N0000186105",
          "N0000009917"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]",
          "Adrenergic alpha1-Agonists [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]",
          "Cyclooxygenase Inhibitor [EPC]",
          "alpha-1 Adrenergic Agonist [EPC]"
        ],
        "unii": [
          "YZI5105V0L",
          "1WS297W6MV"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OMIDRIA",
          "active_ingredients": [
            {
              "name": "KETOROLAC TROMETHAMINE",
              "strength": "EQ 0.3% BASE"
            },
            {
              "name": "PHENYLEPHRINE HYDROCHLORIDE",
              "strength": "EQ 1% BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "IRRIGATION",
          "marketing_status": "Prescription",
          "te_code": "AT"
        }
      ]
    }
  ]
}