{"application":{"applicationId":1518,"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":208,"applicationId":1518,"exclusivityDescription":"Granted for use in dogs weighing less than 5 pounds","exclusivityPeriod":null,"monthPublished":null,"yearPublished":null,"exclusivityExpirationDate":null,"sortOrder":0},{"exclusivityId":210,"applicationId":1518,"exclusivityDescription":"Granted for the treatment and control of adult hookworm A. braziliense.","exclusivityPeriod":null,"monthPublished":null,"yearPublished":null,"exclusivityExpirationDate":null,"sortOrder":0},{"exclusivityId":209,"applicationId":1518,"exclusivityDescription":"Granted for the prevention of\r\nheartworm disease by eliminating the tissue larval stages of Dirofilaria\r\nimmitis for up to a month after infection. They are also approved for the treatment and control of adult Toxocara canis, Toxocara leonina,\r\nAncylostoma caninum, and Uncinaria stenocephala in dogs.","exclusivityPeriod":null,"monthPublished":null,"yearPublished":null,"exclusivityExpirationDate":null,"sortOrder":0}]},"applicationPatent":{"application":null,"patentBean":[]},"documents":{"eaFonsiBean":[],"foi":[{"foiId":543,"applicationId":1518,"approvalTypeId":2,"approvalType":"Supplement","approvalDate":"10/03/1996","summary":"This supplement expands the indications to include the treatment and control of adult hookworms (\n<i>Ancylostoma braziliense</i>).","fileName":"UCM487711.pdf","file":null,"fileContent":null,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null},{"foiId":542,"applicationId":1518,"approvalTypeId":1,"approvalType":"Original","approvalDate":"01/15/1993","summary":"Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of \n<i>Dirofilaria immitis</i> for a month (30 days) after infection), pyrantel pamoate (for the treatment and control of adult \n<i>Toxocara canis, Toxascaris leonina, Ancylostoma caninum</i> and \n<i>Uncinaria stenocephala)</i> in dogs.","fileName":"UCM487710.pdf","file":null,"fileContent":null,"createDate":null,"createOperator":null,"updateDate":null,"updateOperator":null}],"blueBirdLabel":[],"labeling":[],"eaFonsi":[]},"proprietaryPreviewBean":[{"proprietaryNameId":2031,"applicationId":null,"statusDescription":"RX","doseFormName":"Tablet (Chewable)","proprietaryName":"Heartgard® Plus","specifications":"Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.","sortOrder":0,"routes":["Oral"],"withdrawals":[],"species":{"Dogs:29":"Dog, Excluding Under 6 Weeks Age"},"ailHeader":[{"ailHeader":"Dogs","ails":[{"dosageAmount":"A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight.\r\nup to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate\r\n26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate\r\n51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate","indication":"To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae (<i>Dirofilaria immitis</i>) for a month (30 days) after infection.  For the treatment and control of ascarids (<i>Toxocara canis</i>, <i>Toxascaris leonine</i>), and hookworms (<i>Ancylostoma caninum</i>, <i>A braziliense</i>, and <i>Uncinaria stenocephala</i>).","limitation":"Use monthly.  Recommended for dogs 6 weeks of age or older.  Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult <i>D. immitis</i>.  Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus."}]}]}],"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>"},{"activeIngredientName":"Pyrantel Pamoate","activeIngredientTolerance":null}],"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"}}