{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20111109",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40050",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s002lbl.pdf",
              "date": "20111110",
              "type": "Label"
            },
            {
              "id": "32084",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s002ltr.pdf",
              "date": "20111114",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20240722",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79150",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201152Orig1s015ltr.pdf",
              "date": "20240723",
              "type": "Letter"
            },
            {
              "id": "79163",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201152s015lbl.pdf",
              "date": "20240724",
              "type": "Label"
            },
            {
              "id": "79164",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201152s015lbl.pdf#page=18",
              "date": "20240724",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20180924",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "55610",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201152s013lbl.pdf",
              "date": "20180925",
              "type": "Label"
            },
            {
              "id": "55744",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201152Orig1s013ltr.pdf",
              "date": "20181001",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140127",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9863",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201152Orig1s007ltr.pdf",
              "date": "20140128",
              "type": "Letter"
            },
            {
              "id": "18993",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201152s007lbl.pdf",
              "date": "20140128",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20120928",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9862",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s005ltr.pdf",
              "date": "20121003",
              "type": "Letter"
            },
            {
              "id": "18992",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005lbl.pdf",
              "date": "20121004",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110506",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "9860",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf",
              "date": "20110510",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110325",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "44830",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000SumR.pdf",
              "date": "20120629",
              "type": "Summary Review"
            },
            {
              "id": "51402",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/Nevirapine-201152-Clinpharm-PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51403",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/Nevirapine-201152-Statistical-PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "54064",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/Nevirapine-201152-Clinical-PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "9859",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s000ltr.pdf",
              "date": "20110329",
              "type": "Letter"
            },
            {
              "id": "18990",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf",
              "date": "20110329",
              "type": "Label"
            },
            {
              "id": "22844",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000TOC.html",
              "date": "20120629",
              "type": "Review"
            },
            {
              "id": "24098",
              "title": "Medication Guide",
              "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089818.pdf",
              "date": "20111117",
              "type": "Other"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20220610",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71276",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201152Orig1s014ltr.pdf",
              "date": "20220613",
              "type": "Letter"
            },
            {
              "id": "71318",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf",
              "date": "20220615",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20170327",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47739",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201152s010lbl.pdf",
              "date": "20170328",
              "type": "Label"
            },
            {
              "id": "47764",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201152Orig1s010ltr.pdf",
              "date": "20170329",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20121108",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9861",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s004ltr.pdf",
              "date": "20121113",
              "type": "Letter"
            },
            {
              "id": "18991",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004lbl.pdf",
              "date": "20121108",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA201152",
      "sponsor_name": "BOEHRINGER INGELHEIM",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "VIRAMUNE XR",
          "active_ingredients": [
            {
              "name": "NEVIRAPINE",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "TBD"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VIRAMUNE XR",
          "active_ingredients": [
            {
              "name": "NEVIRAPINE",
              "strength": "400MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        }
      ]
    }
  ]
}