<?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="a1e6da2e-ddb9-47e7-b334-8d7bb7fc5fc4"/>
   <code code="53409-9" codeSystem="2.16.840.1.113883.6.1" displayName="BULK INGREDIENT"/>
   <title>Pimobendan</title>
   <effectiveTime value="20190905"/>
   <setId root="58b0202d-b53d-4148-83b1-d42791c4024a"/>
   <versionNumber value="2"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="202872487"/>
            <name>H3 Medical Inc.</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="202872487"/>
                        <name>H3 Medical Inc.</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C73607" displayName="relabel" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <product>
                              <manufacturedProduct classCode="MANU">
                                 <manufacturedMaterialKind>
                                    <code code="63732-2045" codeSystem="2.16.840.1.113883.6.69"/>
                                 </manufacturedMaterialKind>
                              </manufacturedProduct>
                           </product>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="7237f6e3-0fd7-418d-bb18-a28f943d5f87"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20190905"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="63732-2045" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Pimobendan</name>
                        <formCode code="C42972" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Pimobendan</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="1" unit="g"/>
                              <denominator value="1" unit="g"/>
                           </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 value="1000" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="63732-2045-6" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43169" displayName="BOTTLE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20190401"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="5000" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="63732-2045-7" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C79136" displayName="PAIL" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20190401"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="10000" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="63732-2045-8" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C79136" displayName="PAIL" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20190401"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20190401"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <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>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C48623" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NOT APPLICABLE"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="L1415e3ab-7699-4d5b-bf31-f4163b6e930f">
               <id root="abccdaa7-5512-4122-b0dc-5089874e5ca5"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Bulk Ingredient. Principle Display Panel</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L5bd98df4-cad5-4f2e-af44-2dc2eb414416"/>
                  </paragraph>
               </text>
               <effectiveTime value="20190905"/>
               <component>
                  <observationMedia ID="L5bd98df4-cad5-4f2e-af44-2dc2eb414416">
                     <text>Pimobendan</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>