{"application":{"applicationId":1510,"applicationNumber":0,"applicationType":null,"applicationStatusCode":null,"publish":false,"noohDate":null,"mode":null,"pioneerApplicationNumber":0},"applicationSponsor":null,"applicationProprietary":null,"applicationIngredients":null,"applicationExclusivity":{"application":null,"exclusivityBean":[]},"applicationPatent":{"application":null,"patentBean":[]},"documents":{"eaFonsiBean":[],"foi":[{"foiId":3669,"applicationId":1510,"approvalTypeId":1,"approvalType":"Original","approvalDate":"07/03/1989","summary":"<p> <font size=\"2\">For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (</font><i><font face=\"Verdana,Verdana\" size=\"2\"><font face=\"Verdana,Verdana\" size=\"2\">Dirofilaria immitis</font></font></i><font size=\"2\">) up to a month after infection. </font></p>","fileName":"N140886_ Orig_7_3_1989.pdf","file":null,"fileContent":null,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null}],"blueBirdLabel":[],"labeling":[],"eaFonsi":[]},"proprietaryPreviewBean":[{"proprietaryNameId":2020,"applicationId":null,"statusDescription":"RX","doseFormName":"Tablet (Chewable)","proprietaryName":"Heartgard® Chewables For Dogs","specifications":"Each chewable contains 68, 136, or 272 micrograms of ivermectin.","sortOrder":0,"routes":["Oral"],"withdrawals":[],"species":{"Dogs:29":"Dog, Excluding Under 6 Weeks Age"},"ailHeader":[{"ailHeader":"Dogs","ails":[{"dosageAmount":"6.0 micrograms per kilogram body weight (2.72 micrograms per pound), minimum. \r\nup to 25 pounds, 68 micrograms; \r\n26 to 50 pounds 136 micrograms; \r\n51 to 100 pounds, 272 micrograms;   \r\n100 pounds, a combination of the appropriate tablets.","indication":"To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (<i>Dirofilaria immitis</i>) for 1 month (30 days) after infection.","limitation":"Use once-a-month.  Recommended for dogs 6 weeks of age and older.  Initial use within 1 month after first exposure to mosquitoes. Final use within 1 month after last exposure to mosquitoes. All dogs should be tested for existing heartworm infection before starting treatment with HEARGARD which is not effective against adult <i>D. immitis</i>. Infected dogs must be treated to remove adult heartworms and microfilariae prior to initiating a program with HEARGARD. Federal law restricts this drug to use by or on the order of a licensed veterinarian."}]}]}],"ingredientsPreviewBean":[{"activeIngredientName":"Ivermectin","activeIngredientTolerance":"<p>A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 1.6 parts per million. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 0.65 parts per million</p>"}],"sponsorPreviewBean":{"sponsorName":"Boehringer lngelheim Animal Health USA, Inc.","address1":"4000 Medley Blvd.","address2":"Suite 300","city":"Johns Creek","state":"Georgia","postalCode":"30097","stateCode":"GA","countryName":"United States"}}