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          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "RISPERDAL",
          "active_ingredients": [
            {
              "name": "RISPERIDONE",
              "strength": "0.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "RISPERDAL",
          "active_ingredients": [
            {
              "name": "RISPERIDONE",
              "strength": "5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "RISPERDAL",
          "active_ingredients": [
            {
              "name": "RISPERIDONE",
              "strength": "3MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "RISPERDAL",
          "active_ingredients": [
            {
              "name": "RISPERIDONE",
              "strength": "1MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}