{
  "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": "26",
          "submission_status": "AP",
          "submission_status_date": "20141029",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "2681",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020533Orig1s026ltr.pdf",
              "date": "20141030",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980501",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20160606",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20130421",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20130216",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20060808",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25128",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020533s014LTR.pdf",
              "date": "20060811",
              "type": "Letter"
            },
            {
              "id": "34787",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020533s014lbl.pdf",
              "date": "20060809",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19960924",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "57659",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020533Orig1s000rev.pdf",
              "date": "20190215",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20100219",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25129",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf",
              "date": "20100225",
              "type": "Letter"
            },
            {
              "id": "34788",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf",
              "date": "20100225",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20040811",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12690",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf",
              "date": "20040812",
              "type": "Label"
            },
            {
              "id": "2679",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20533s012ltr.pdf",
              "date": "20040812",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20020717",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20000209",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20121109",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "34790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s029lbl.pdf",
              "date": "20121115",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20181102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56264",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020533s035lbl.pdf",
              "date": "20181105",
              "type": "Label"
            },
            {
              "id": "56351",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020533Orig1s035ltr.pdf",
              "date": "20181108",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20121115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20001102",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41417",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-533s002_Naropin.html",
              "date": "20040628",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20100219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12691",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf",
              "date": "20100225",
              "type": "Label"
            },
            {
              "id": "2680",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf",
              "date": "20100225",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20220615",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71335",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020533Orig1s038ltr.pdf",
              "date": "20220616",
              "type": "Letter"
            },
            {
              "id": "71343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020533s038lbl.pdf",
              "date": "20220616",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20001114",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "20220628",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71477",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020533Orig1s044ltr.pdf",
              "date": "20220629",
              "type": "Letter"
            },
            {
              "id": "72129",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020533Orig1s044lbl.pdf",
              "date": "20220921",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20000622",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20121226",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "34789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s028lbl.pdf",
              "date": "20130107",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20180215",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "52705",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020533Orig1s034ltr.pdf",
              "date": "20180223",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020533",
      "sponsor_name": "FRESENIUS KABI USA",
      "openfda": {
        "application_number": [
          "NDA020533"
        ],
        "brand_name": [
          "NAROPIN"
        ],
        "generic_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-285",
          "63323-286",
          "63323-287",
          "63323-288"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL",
          "INFILTRATION",
          "PERINEURAL"
        ],
        "substance_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1734203",
          "1734204",
          "1734207",
          "1734208",
          "1734347",
          "1734348",
          "1734355",
          "1734356",
          "1734475",
          "1734476",
          "1734479",
          "1734480",
          "1734481",
          "1734482",
          "1734483",
          "1734484",
          "905189",
          "905191",
          "1734084",
          "1734086",
          "1734090",
          "1734091"
        ],
        "spl_id": [
          "324532ac-4e54-4659-a1a2-9ade22a1ed3f",
          "cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9",
          "73218c89-8925-468c-84bf-9960b4b3dc3c",
          "75465ceb-e894-487d-aa80-671fa0841fce"
        ],
        "spl_set_id": [
          "dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7",
          "23d2d448-a744-4877-9f2d-7e57c198da89",
          "c6613708-c1f7-4f5c-91a3-ebbc1d7905c6",
          "56dfabf7-f7a8-4601-b17a-cb16fb995b0f"
        ],
        "package_ndc": [
          "63323-286-41",
          "63323-286-27",
          "63323-286-43",
          "63323-286-38",
          "63323-285-41",
          "63323-285-28",
          "63323-285-53",
          "63323-285-68",
          "63323-285-59",
          "63323-285-73",
          "63323-286-01",
          "63323-286-20",
          "63323-286-05",
          "63323-286-23",
          "63323-286-09",
          "63323-286-31",
          "63323-286-11",
          "63323-286-35",
          "63323-286-03",
          "63323-286-00",
          "63323-286-33",
          "63323-286-63",
          "63323-286-30",
          "63323-287-01",
          "63323-287-20",
          "63323-287-03",
          "63323-287-21",
          "63323-288-01",
          "63323-288-10",
          "63323-288-06",
          "63323-288-20",
          "63323-288-03",
          "63323-288-11",
          "63323-288-07",
          "63323-288-21",
          "63323-285-01",
          "63323-285-10",
          "63323-285-06",
          "63323-285-20",
          "63323-285-03",
          "63323-285-13",
          "63323-285-07",
          "63323-285-23",
          "63323-285-57",
          "63323-285-64",
          "63323-285-51",
          "63323-285-65",
          "63323-285-02",
          "63323-285-61",
          "63323-285-04",
          "63323-285-63",
          "63323-285-55",
          "63323-285-67",
          "63323-288-23",
          "63323-288-29",
          "63323-286-93",
          "63323-286-95",
          "63323-288-25",
          "63323-288-27"
        ],
        "unii": [
          "V910P86109"
        ]
      },
      "products": [
        {
          "product_number": "008",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "150MG/30ML (5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "200MG/100ML (2MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "012",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "150MG/20ML (7.5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "010",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "1GM/200ML (5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "40MG/20ML (2MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "009",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "500MG/100ML (5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "400MG/200ML (2MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "013",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "100MG/10ML (10MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "011",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "200MG/20ML (10MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "100MG/20ML (5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NAROPIN",
          "active_ingredients": [
            {
              "name": "ROPIVACAINE HYDROCHLORIDE",
              "strength": "20MG/10ML (2MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}