{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20260612",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "86268",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206814Orig1s013lbl.pdf",
              "date": "20260616",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20190501",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "58833",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s008lbl.pdf",
              "date": "20190522",
              "type": "Label"
            },
            {
              "id": "58836",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206814Orig1s008ltr.pdf",
              "date": "20190523",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20141222",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 7",
          "submission_class_code_description": "Type 7 - Drug Already Marketed without Approved NDA",
          "application_docs": [
            {
              "id": "43528",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000TOC.html",
              "date": "20150310",
              "type": "Review"
            },
            {
              "id": "44949",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000SumR.pdf",
              "date": "20150310",
              "type": "Summary Review"
            },
            {
              "id": "19736",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206814lbl.pdf",
              "date": "20141223",
              "type": "Label"
            },
            {
              "id": "32829",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206814Orig1s000ltr.pdf",
              "date": "20141230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20200305",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62054",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206814s009lbl.pdf",
              "date": "20200306",
              "type": "Label"
            },
            {
              "id": "62078",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206814Orig1s009ltr.pdf",
              "date": "20200309",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20190204",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57587",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206814Orig1s007ltr_.pdf",
              "date": "20190213",
              "type": "Letter"
            },
            {
              "id": "57614",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf",
              "date": "20190215",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150714",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA206814",
      "sponsor_name": "GENUS LIFESCIENCES",
      "openfda": {
        "application_number": [
          "NDA206814"
        ],
        "brand_name": [
          "POKONZA POTASSIUM CHLORIDE",
          "POTASSIUM CHLORIDE"
        ],
        "generic_name": [
          "POTASSIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Carwin Pharmaceutical Associates, LLC",
          "Genus Lifesciences",
          "Endo USA, Inc."
        ],
        "product_ndc": [
          "15370-307",
          "64950-320",
          "64950-322",
          "0603-1542",
          "0603-1543"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM CHLORIDE"
        ],
        "rxcui": [
          "2734000",
          "2734004",
          "312515",
          "314182"
        ],
        "spl_id": [
          "63d621b7-ee4e-4230-be7e-f186ea90fe11",
          "2fe5566d-af35-4b1a-8ed6-a7b803dfc896",
          "f57f6d4a-b7d8-407b-8259-19dff55a841d"
        ],
        "spl_set_id": [
          "2d938cbf-27aa-4f9c-a582-5564d3b72465",
          "14cd12ee-a4a3-465a-9550-58c9ef0e4f21",
          "e5214432-3517-4a90-9412-036752bd1139"
        ],
        "package_ndc": [
          "15370-307-04",
          "15370-307-08",
          "15370-307-16",
          "64950-320-47",
          "64950-320-99",
          "64950-322-47",
          "0603-1542-58",
          "0603-1543-58"
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "POKONZA",
          "active_ingredients": [
            {
              "name": "POTASSIUM CHLORIDE",
              "strength": "10MEQ/15ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "POTASSIUM CHLORIDE",
          "active_ingredients": [
            {
              "name": "POTASSIUM CHLORIDE",
              "strength": "20MEQ/15ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "POTASSIUM CHLORIDE",
          "active_ingredients": [
            {
              "name": "POTASSIUM CHLORIDE",
              "strength": "40MEQ/15ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}