{"application":{"applicationId":1499,"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":270,"applicationId":1499,"exclusivityDescription":"Granted for a new drug form,  for use in cats,  with new therapeutic claim.","exclusivityPeriod":null,"monthPublished":null,"yearPublished":null,"exclusivityExpirationDate":null,"sortOrder":0}]},"applicationPatent":{"application":null,"patentBean":[]},"documents":{"eaFonsiBean":[],"foi":[{"foiId":613,"applicationId":1499,"approvalTypeId":1,"approvalType":"Original","approvalDate":"12/23/1996","summary":"Heartgard® for Cats is indicated for the prevention of feline heartworm disease by eliminating the tissue stage of heartworm larvae (\n<i>Dirofilaria immitis</i>) for a month (30 days) after infection, and for the removal and control of adult and immature (L4) hookworms (\n<i>Ancylostoma tubaeforme</i> and \n<i>A. braziliense</i>).","fileName":"UCM488659.pdf","file":null,"fileContent":null,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null}],"blueBirdLabel":[],"labeling":[],"eaFonsi":[]},"proprietaryPreviewBean":[{"proprietaryNameId":2004,"applicationId":null,"statusDescription":"RX","doseFormName":"Tablet (Chewable)","proprietaryName":"Heartgard® for Cats","specifications":"Each chewable contains 55 or 165 micrograms of ivermectin.","sortOrder":0,"routes":["Oral"],"withdrawals":[],"species":{"Cats (Domestic):1039":"Cats and kittens, excluding kittens under 6 weeks age"},"ailHeader":[{"ailHeader":"Cats (6 Weeks of Age and Older)","ails":[{"dosageAmount":"Up to 2.3 kilograms (up to 5 pounds), 55 micrograms; 2.3 - 6.8 kilograms (5 to 15 pounds), 165 micrograms; over 6.8 kilograms (15 pounds), a combination of appropriate chewables (recommended minimum dose of 24 micrograms of ivermectin per kilogram of body weight (10.9 micrograms per pound).","indication":"To prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae <i>Dirofilaria immitis</i> for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms <i>Ancylostoma tubaeforme</i> and <i>A. braziliense</i>.","limitation":"For use in cats 6 weeks of age and older.  Administer once a month.  The initial dose must be given within a month after cats first exposure to mosquitoes.  The final dose must be given within a month after the cats last exposure to mosquitoes."}]}]}],"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"}}