{
  "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": "2026-07-30",
    "results": {
      "skip": 0,
      "limit": 1,
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        "duplicatesource": "BRISTOL MYERS SQUIBB",
        "duplicatenumb": "GB-BRISTOL-MYERS SQUIBB COMPANY-20393971"
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      "patient": {
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        "patientonsetageunit": "801",
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        "reaction": [
          {
            "reactionmeddraversionpt": "18.1",
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          },
          {
            "reactionmeddraversionpt": "18.1",
            "reactionmeddrapt": "Stillbirth",
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          {
            "reactionmeddraversionpt": "18.1",
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          {
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                "NDA022417",
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                "NORVIR"
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                "RITONAVIR"
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              "manufacturer_name": [
                "AbbVie Inc."
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                "0074-2340",
                "0074-3333",
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                "HUMAN PRESCRIPTION DRUG"
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                "Cytochrome P450 2C19 Inducers [MoA]",
                "Cytochrome P450 3A Inducers [MoA]",
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                "Cytochrome P450 3A4 Inhibitors [MoA]",
                "Cytochrome P450 1A2 Inducers [MoA]",
                "Cytochrome P450 2C9 Inducers [MoA]",
                "Cytochrome P450 2B6 Inducers [MoA]",
                "UDP Glucuronosyltransferases Inducers [MoA]"
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                "Cytochrome P450 3A Inhibitor [EPC]",
                "Protease Inhibitor [EPC]"
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                "O3J8G9O825"
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              "application_number": [
                "ANDA091673",
                "ANDA204806"
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                "ATAZANAVIR SULFATE"
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                "ATAZANAVIR SULFATE",
                "ATAZANAVIR"
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                "Teva Pharmaceuticals USA, Inc.",
                "Aurobindo Pharma Limited"
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                "0093-5526",
                "0093-5527",
                "0093-5528",
                "65862-710",
                "65862-711",
                "65862-712",
                "65862-713"
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                "HUMAN PRESCRIPTION DRUG"
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                "ORAL"
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              "substance_name": [
                "ATAZANAVIR SULFATE"
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                "402246",
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                "664741",
                "402245"
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                "61209ea1-63c7-43fc-ac32-d840a8a0906a",
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                "0093-5526-06",
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                "65862-713-30",
                "65862-713-90",
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                "65862-713-10",
                "65862-713-03"
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                "4MT4VIE29P"
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          {
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              "activesubstancename": "EMTRICITABINE\\TENOFOVIR DISOPROXIL FUMARATE"
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              "application_number": [
                "NDA021752"
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                "TRUVADA"
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              "generic_name": [
                "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE"
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                "Gilead Sciences, Inc"
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                "61958-0701",
                "61958-0703",
                "61958-0704",
                "61958-0705"
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                "HUMAN PRESCRIPTION DRUG"
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                "ORAL"
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                "EMTRICITABINE",
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                "61958-0701-1",
                "61958-0703-1",
                "61958-0704-1",
                "61958-0705-1"
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              "nui": [
                "N0000175462",
                "M0015066",
                "N0000009947"
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              "pharm_class_epc": [
                "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"
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              "pharm_class_cs": [
                "Nucleosides [CS]"
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                "Nucleoside Reverse Transcriptase Inhibitors [MoA]"
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                "G70B4ETF4S",
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          {
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            "drugstartdate": "20130509",
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            "actiondrug": "5",
            "activesubstance": {
              "activesubstancename": "RALTEGRAVIR POTASSIUM"
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            "openfda": {
              "application_number": [
                "NDA022145",
                "NDA203045",
                "NDA205786"
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              "brand_name": [
                "ISENTRESS"
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                "RALTEGRAVIR"
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              "manufacturer_name": [
                "Merck Sharp & Dohme LLC"
              ],
              "product_ndc": [
                "0006-0227",
                "0006-0477",
                "0006-0473",
                "0006-3603",
                "0006-3080"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "RALTEGRAVIR POTASSIUM"
              ],
              "rxcui": [
                "744842",
                "744846",
                "1235588",
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                "1486838",
                "1486841",
                "1924313",
                "1924315"
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              "spl_id": [
                "70b9b593-db43-43ad-8808-a1c86c048145"
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              "spl_set_id": [
                "89a5ec53-d956-4329-8004-0f40f51c88a3"
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              "package_ndc": [
                "0006-0227-61",
                "0006-0477-61",
                "0006-0473-61",
                "0006-3603-01",
                "0006-3603-60",
                "0006-3603-61",
                "0006-3080-01"
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              "unii": [
                "43Y000U234"
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          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 2013"
        }
      }
    }
  ]
}