{"application":{"applicationId":222,"applicationNumber":0,"applicationType":null,"applicationStatusCode":null,"publish":false,"noohDate":null,"mode":null,"pioneerApplicationNumber":0},"applicationSponsor":null,"applicationProprietary":null,"applicationIngredients":null,"applicationExclusivity":{"application":null,"exclusivityBean":[{"exclusivityId":23,"applicationId":222,"exclusivityDescription":"No product using tepoxalin as an active ingredient has been previously approved for use in dogs in any other application.","exclusivityPeriod":5,"monthPublished":"07","yearPublished":"2003","exclusivityExpirationDate":"03/31/2008","sortOrder":0}]},"applicationPatent":{"application":null,"patentBean":[]},"documents":{"eaFonsiBean":[],"foi":[{"foiId":706,"applicationId":222,"approvalTypeId":1,"approvalType":"Original","approvalDate":"03/31/2003","summary":"ZUBRIN™ (tepoxalin) Tablets are indicated for the control of pain and inflammation associated with osteoarthritis in dogs.","fileName":"ucm117603.pdf","file":null,"fileContent":null,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null}],"blueBirdLabel":[],"labeling":[],"eaFonsi":[]},"proprietaryPreviewBean":[{"proprietaryNameId":276,"applicationId":null,"statusDescription":"RX","doseFormName":"Tablet","proprietaryName":"Zubrin™ Rapidly-Disintegrating Tablets","specifications":"Each rapidly- disintegrating tablet contains 30, 50, 100, or 200 mg tepoxalin.","sortOrder":0,"routes":["Oral"],"withdrawals":[],"species":{"Dogs:43":"Dog, No Use Class Stated Or Implied"},"ailHeader":[{"ailHeader":"Dogs","ails":[{"dosageAmount":"Administer 10 mg/kg (4.5 mg/lb) or 20 mg/kg (9.1 mg/lb) on the initial day of treatment, followed by a daily maintenance dose of 10 mg/kg. Due to observed variability in tepoxalin metabolism, a higher initial dose of 20 mg/kg may be given to increase the likelihood that plasma active metabolite levels will reach a minimum effective concentration following the first oral  administration. \r\nThe duration of treatment at 10 mg/kg should be based on clinical response and patient tolerance of drug treatment.","indication":"For the control of pain and inflammation associated with osteoarthritis in dogs.","limitation":"Federal law restricts this drug to use by or on the order of a licensed veterinarian."}]}]}],"ingredientsPreviewBean":[{"activeIngredientName":"Tepoxalin","activeIngredientTolerance":null}],"sponsorPreviewBean":{"sponsorName":"Intervet, Inc.","address1":"126 E. Lincoln Ave","address2":null,"city":"Rahway","state":"New Jersey","postalCode":"07065","stateCode":"NJ","countryName":"United States"}}