<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="2892b8b1-f49a-4112-acf0-7dc220cff5d0"/>
   <code code="81203-2" displayName="BULK INGREDIENT - ANIMAL DRUG" codeSystem="2.16.840.1.113883.6.1"/>
   <title>Pimobendan</title>
   <effectiveTime value="20230104"/>
   <setId root="f78797ff-e069-4cab-94bb-5e971518e219"/>
   <versionNumber value="2"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="544452690" root="1.3.6.1.4.1.519.1"/>
            <name>Tianjin Pharmaceutical Innovation Co.,Ltd.</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="544452690"/>
                        <name>Tianjin Pharmaceutical Innovation Co.,Ltd.</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C82401" displayName="api manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="0f4e55a0-634d-4243-9362-cdbb516a6c07"/>
               <code code="48780-1" displayName="SPL listing data elements section" codeSystem="2.16.840.1.113883.6.1"/>
               <effectiveTime value="20221014"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86122-002" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Pimobendan</name>
                        <formCode code="C42972" displayName="POWDER" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Pimobendan</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="kg" value="1"/>
                              <denominator unit="kg" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="34AP3BBP9T" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PIMOBENDAN</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="34AP3BBP9T" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PIMOBENDAN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="kg" value="5"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86122-002-27" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" displayName="BAG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="10" unit="kg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86122-002-28" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" displayName="BAG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="0.5" unit="kg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86122-002-22" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" displayName="BAG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="0.1" unit="kg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86122-002-21" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" displayName="BAG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="0.05" unit="kg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86122-002-20" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" displayName="BAG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="1" unit="kg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86122-002-29" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43167" displayName="BAG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <code code="C98252" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="bulk ingredient for animal drug compounding"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20221013"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE"/>
                        </characteristic>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C48623" displayName="NOT APPLICABLE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section>
               <id root="b9ebfd71-0dbf-4564-a590-fdfed1c40735"/>
               <code codeSystem="2.16.840.1.113883.6.1" code="51945-4" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>
                  <content styleCode="bold">PRINCIPAL DISPLAY PANEL – BULK PRODUCT</content>
               </title>
               <text>
                  <paragraph>PIMOBENDANLISTING(2).jpg</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Ld8a27fb4-3637-4913-ba10-9acb03a61a1c"/>
                  </paragraph>
               </text>
               <effectiveTime value="20230104"/>
               <component>
                  <observationMedia ID="Ld8a27fb4-3637-4913-ba10-9acb03a61a1c">
                     <text>PIMOBENDANLISTING(2).jpg</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="PIMOBENDANLISTING(2).jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>