{
  "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": "22",
          "submission_status": "AP",
          "submission_status_date": "20181129",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56633",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021920Orig1s022lbl.pdf",
              "date": "20181204",
              "type": "Label"
            },
            {
              "id": "56821",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021920Orig1s022ltr.pdf",
              "date": "20181220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20090415",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6446",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s010ltr.pdf",
              "date": "20090421",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060217",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "42350",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021920s000TOC.html",
              "date": "20080222",
              "type": "Review"
            },
            {
              "id": "6445",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021920s000ltr.pdf",
              "date": "20060301",
              "type": "Letter"
            },
            {
              "id": "16568",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021920s000lbl.pdf",
              "date": "20060228",
              "type": "Label"
            },
            {
              "id": "23683",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110423.htm",
              "date": "20060302",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20200227",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61992",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021920Orig1s027ltr.pdf",
              "date": "20200228",
              "type": "Letter"
            },
            {
              "id": "61993",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021920Orig1s027lbl.pdf",
              "date": "20200228",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20260115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84781",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021920Orig1s041lbl.pdf",
              "date": "20260127",
              "type": "Label"
            },
            {
              "id": "84782",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021920Orig1s041ltr.pdf",
              "date": "20260120",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20170316",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021920Orig1s019lbl.pdf",
              "date": "20170317",
              "type": "Label"
            },
            {
              "id": "47595",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021920Orig1s019ltr.pdf",
              "date": "20170320",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20201212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65594",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021920Orig1s033ltr.pdf",
              "date": "20201215",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20191026",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60694",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s025ltr.pdf",
              "date": "20191029",
              "type": "Letter"
            },
            {
              "id": "60695",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s025lbl.pdf",
              "date": "20191029",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20120613",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6448",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021920s017ltr.pdf",
              "date": "20120615",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20190220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57739",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s023lbl.pdf",
              "date": "20190221",
              "type": "Label"
            },
            {
              "id": "57769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s023ltr.pdf",
              "date": "20190222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20100812",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28843",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021920s013ltr.pdf",
              "date": "20100816",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20090714",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37875",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021920s011lbl.pdf",
              "date": "20090724",
              "type": "Label"
            },
            {
              "id": "6447",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s011ltr.pdf",
              "date": "20090717",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20211213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69586",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021920Orig1s036ltr.pdf",
              "date": "20211216",
              "type": "Letter"
            },
            {
              "id": "69587",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021920Orig1s036lbl.pdf",
              "date": "20211216",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20200430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021920Orig1s028lbl.pdf",
              "date": "20200501",
              "type": "Label"
            },
            {
              "id": "62790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021920Orig1s028ltr.pdf",
              "date": "20200501",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20191209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61223",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s026ltr.pdf",
              "date": "20191211",
              "type": "Letter"
            },
            {
              "id": "61227",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s026lbl.pdf",
              "date": "20191211",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20130401",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37876",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021920Orig1s018lbl.pdf",
              "date": "20131125",
              "type": "Label"
            },
            {
              "id": "6449",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021920Orig1s018ltr.pdf",
              "date": "20130403",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021920",
      "sponsor_name": "BIONPHARMA",
      "openfda": {
        "application_number": [
          "NDA021920"
        ],
        "brand_name": [
          "NAPROXEN SODIUM",
          "ALEVE",
          "ALEVE EASY OPEN ARTHRITIS CAP"
        ],
        "generic_name": [
          "NAPROXEN SODIUM"
        ],
        "manufacturer_name": [
          "Bionpharma Inc.",
          "TOP CARE (Topco Associates LLC)",
          "HEB",
          "MEIJER DISTRIBUTION INC",
          "VALU MERCHANDISERS COMPANY",
          "Wal-Mart Stores, Inc.",
          "WALGREEN COMPANY",
          "KROGER COMPANY",
          "Albertsons Companies",
          "Rite Aid Corporation",
          "Bayer HealthCare LLC.",
          "DISCOUNT DRUG MART, INC.",
          "Amazon.com Services LLC",
          "SUPERVALU INC",
          "AMERISOURCE BERGEN",
          "TARGET Corporation",
          "CHAIN DRUG MARKETING ASSOCIATION INC.",
          "Premier Value Alliance LLC"
        ],
        "product_ndc": [
          "69452-259",
          "36800-204",
          "37808-049",
          "41250-225",
          "69452-179",
          "63941-681",
          "49035-382",
          "0363-0102",
          "30142-285",
          "69452-284",
          "21130-948",
          "11822-0788",
          "0363-0177",
          "0280-6080",
          "53943-179",
          "0280-6091",
          "72288-312",
          "41163-079",
          "46122-780",
          "11673-651",
          "63868-830",
          "68016-056"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NAPROXEN SODIUM"
        ],
        "rxcui": [
          "1112231",
          "1112233"
        ],
        "spl_id": [
          "51a1be90-a17c-8e7f-e063-6394a90a1cb0",
          "f0fce18a-cc1c-347f-e053-2a95a90ac3b9",
          "f0fcbeef-9c57-79cb-e053-2a95a90aa504",
          "45c5dfca-97dc-cb72-e063-6294a90a8f98",
          "0d85dc59-4954-47fc-e063-6394a90a01cd",
          "06d2daf1-3067-95e9-e063-6294a90aa789",
          "f0fb53cd-5c61-6417-e053-2995a90a6c61",
          "f0fb89d5-c3fd-0ff2-e053-2995a90a388d",
          "f0fa8adc-3f3b-69aa-e053-2995a90a80d8",
          "4fe826c9-b874-7e70-e063-6294a90a641b",
          "23615188-2795-b75b-e063-6394a90a9728",
          "f6075fe4-84b6-3b21-e053-2a95a90a9f99",
          "da638473-feb5-ccf1-e053-2a95a90a80d3",
          "4526c253-b571-1d84-e063-6394a90ae3f9",
          "da537372-a936-4ef8-e053-2a95a90a7827",
          "4526c253-b572-1d84-e063-6394a90ae3f9",
          "5075f7bb-8b66-de7b-e063-6394a90a4d24",
          "94ab3a89-85d0-4985-ad99-43bd7bbf9e48",
          "16b3bbf6-8bb7-1547-e063-6294a90a5062",
          "45723671-6285-3bb2-e063-6294a90ab0b8",
          "f060cee9-5392-7126-e053-2995a90afbf1",
          "803b1569-46f0-4937-842c-0c363fe0ed79"
        ],
        "spl_set_id": [
          "9343c79f-9994-4599-bcfe-0a93e49d726e",
          "c62b7fa0-5ae9-276c-e053-2995a90ade25",
          "df8ea301-c48b-4da4-9e8e-5c69cac6cba7",
          "89f82399-9f71-49dd-8710-b60f346c576c",
          "3e10256f-0a5f-49e4-9518-a72b10490f89",
          "fed305f1-e32d-e1ff-e053-6294a90a273d",
          "073ecef7-f5b1-4ee0-98bc-82972e3d84f9",
          "a13bd208-f29f-1cbc-e053-2995a90a08ba",
          "7487e685-ea64-43a2-9a4e-f5278840be04",
          "ba4f927a-4bbe-0d87-e053-2995a90a8c20",
          "f9df7495-9da7-8838-e053-6294a90a6fda",
          "a359c47e-e2b4-5560-e053-2a95a90a2844",
          "462a7e41-b899-4e08-8113-b48ece0ad8d8",
          "1266393e-b55e-4e34-9710-0b87209f4158",
          "b00c0e86-4c0b-45bf-948f-824ea0f09e39",
          "3b5442c6-c6e1-4df3-8cec-40bbb4ec469f",
          "04a298dc-c525-8198-e063-6294a90a6f96",
          "1aedc0a1-466a-40c6-bb4c-53b7e8f83aff",
          "16b3bbee-4881-b439-e063-6394a90a7c8f",
          "36bf8594-9303-c816-e063-6294a90af705",
          "c482db41-b115-c24f-e053-2a95a90a2947",
          "803b1569-46f0-4937-842c-0c363fe0ed79"
        ],
        "package_ndc": [
          "69452-259-78",
          "69452-259-22",
          "69452-259-25",
          "69452-259-21",
          "36800-204-11",
          "36800-204-16",
          "36800-204-78",
          "37808-049-78",
          "37808-049-15",
          "37808-049-16",
          "41250-225-15",
          "41250-225-78",
          "41250-225-16",
          "69452-179-79",
          "69452-179-11",
          "69452-179-15",
          "69452-179-78",
          "69452-179-20",
          "69452-179-22",
          "63941-681-16",
          "49035-382-78",
          "49035-382-22",
          "0363-0102-15",
          "30142-285-78",
          "30142-285-22",
          "69452-284-25",
          "21130-948-11",
          "21130-948-78",
          "21130-948-15",
          "21130-948-16",
          "11822-0788-4",
          "11822-0788-5",
          "11822-0788-6",
          "0363-0177-11",
          "0363-0177-15",
          "0363-0177-78",
          "0363-0177-22",
          "0363-0177-25",
          "0363-0177-99",
          "0363-0177-16",
          "0280-6080-20",
          "0280-6080-40",
          "0280-6080-80",
          "0280-6080-16",
          "0280-6080-01",
          "0280-6080-02",
          "0280-6080-03",
          "0280-6080-04",
          "53943-179-11",
          "0280-6091-80",
          "72288-312-25",
          "41163-079-15",
          "46122-780-64",
          "11673-651-78",
          "63868-830-20",
          "68016-056-40"
        ],
        "unii": [
          "9TN87S3A3C"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NAPROXEN SODIUM",
          "active_ingredients": [
            {
              "name": "NAPROXEN SODIUM",
              "strength": "EQ 200MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}