<?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="63b50256-953c-47ad-af38-11a3286bd1b7"/>
   <code code="81203-2" codeSystem="2.16.840.1.113883.6.1" displayName="BULK INGREDIENT - ANIMAL DRUG"/>
   <title>Pimobendan</title>
   <effectiveTime value="20260312"/>
   <setId root="fa99a292-37ca-4b10-9341-45707cfdf1e4"/>
   <versionNumber value="7"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="204011316"/>
            <name>AX Pharmaceutical Corp</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="204011316"/>
                        <name>AX Pharmaceutical Corp</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C73607" displayName="relabel" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                     <performance>
                        <actDefinition>
                           <code code="C73606" displayName="repack" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="2463fba5-da23-4281-b8e2-cc29ed1ba35a"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20260226"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="73377-263" 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="10" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="73377-263-01" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="25" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="73377-263-02" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="22" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="73377-263-03" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="100" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="73377-263-04" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="95" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="73377-263-05" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="500" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="73377-263-06" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" 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>
                        <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>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20240131"/>
                           </effectiveTime>
                        </marketingAct>
                     </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="Ld0b34599-cbad-494b-b692-f6c45c04e90d">
               <id root="5ab59dbd-0559-4666-8021-3a5dcb886cfc"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Pimobendan</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="Lcf9d31ad-ca67-4bed-869b-e47a537fe82d"/>
                     <renderMultiMedia referencedObject="L4e9ce068-d44a-4754-a673-206f9363b4c8"/>
                     <renderMultiMedia referencedObject="L121091bc-7f0c-4c59-8b49-397cc00ce104"/>
                     <renderMultiMedia referencedObject="L2832b4c0-ff35-4116-a017-4886bd29dae8"/>
                     <renderMultiMedia referencedObject="Ld9f2afc6-dc42-411a-af84-7281cde0266e"/>
                     <renderMultiMedia referencedObject="Lc555b811-5423-4593-8e0f-617bff4f965f"/>
                  </paragraph>
               </text>
               <effectiveTime value="20260312"/>
               <component>
                  <observationMedia ID="Lcf9d31ad-ca67-4bed-869b-e47a537fe82d">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan 10g Vet.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L4e9ce068-d44a-4754-a673-206f9363b4c8">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan 22g Vet.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L121091bc-7f0c-4c59-8b49-397cc00ce104">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan 25g Vet.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="L2832b4c0-ff35-4116-a017-4886bd29dae8">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan 95G M K218-25F29P1O vet Tesma.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Ld9f2afc6-dc42-411a-af84-7281cde0266e">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan 100G M K218-25F29P1O vet Tesma.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Lc555b811-5423-4593-8e0f-617bff4f965f">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Pimobendan 500G M L010-25I14SH  vet Tesma.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>