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              "type": "Medication Guide"
            }
          ]
        }
      ],
      "application_number": "NDA020822",
      "sponsor_name": "ABBVIE",
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "CELEXA",
          "active_ingredients": [
            {
              "name": "CITALOPRAM HYDROBROMIDE",
              "strength": "EQ 40MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CELEXA",
          "active_ingredients": [
            {
              "name": "CITALOPRAM HYDROBROMIDE",
              "strength": "EQ 10MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "CELEXA",
          "active_ingredients": [
            {
              "name": "CITALOPRAM HYDROBROMIDE",
              "strength": "EQ 60MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "CELEXA",
          "active_ingredients": [
            {
              "name": "CITALOPRAM HYDROBROMIDE",
              "strength": "EQ 20MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}