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              "id": "56941",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050662Orig1s060, 050698Orig1s040, 050775Orig1s028Ltr.pdf",
              "date": "20181231",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA050698",
      "sponsor_name": "ABBVIE",
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "BIAXIN",
          "active_ingredients": [
            {
              "name": "CLARITHROMYCIN",
              "strength": "187MG/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BIAXIN",
          "active_ingredients": [
            {
              "name": "CLARITHROMYCIN",
              "strength": "125MG/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "BIAXIN",
          "active_ingredients": [
            {
              "name": "CLARITHROMYCIN",
              "strength": "250MG/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}