<?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="081332dc-19b0-42ed-91aa-5dfda3cff878"/>
   <code code="81203-2" codeSystem="2.16.840.1.113883.6.1" displayName="BULK INGREDIENT - ANIMAL DRUG"/>
   <title/>
   <effectiveTime value="20250902"/>
   <setId root="2e06e522-7f32-4dcd-a715-1532bb8ad4e4"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="405186518"/>
            <name>Hunan Huateng Pharma Tech Co., Ltd.</name>
            <assignedEntity>
               <assignedOrganization>
                  <id extension="405186518" root="1.3.6.1.4.1.519.1"/>
                  <name>Hunan Huateng Pharma Tech Co., Ltd.</name>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="405186518"/>
                        <name>Hunan Huateng Pharma Tech 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="a0a3313a-beb3-423e-917f-9d42de8fefee"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <title/>
               <text/>
               <effectiveTime value="20250902"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="86197-007" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Toceranib Phosphate</name>
                        <formCode code="C42972" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Toceranib Phosphate</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="1" unit="g"/>
                              <denominator value="1" unit="g"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="24F9PF7J3R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TOCERANIB PHOSPHATE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="59L7Y0530C" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>TOCERANIB</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="500" unit="g"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="86197-007-01" 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>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20250501"/>
                           </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>
                     <subjectOf>
                        <characteristic>
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48330" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="yellow" xsi:type="CE"/>
                        </characteristic>
                     </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="L3ae6b60c-f7a6-4667-8429-2f625e73a5e7">
               <id root="82179c52-74c2-4c37-97cd-2b2db6c06632"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L801b97f8-21e2-4d12-9ee1-501d0e9d89b9"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250902"/>
               <component>
                  <observationMedia ID="L801b97f8-21e2-4d12-9ee1-501d0e9d89b9">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="ToceranibPhosphate500gLabel.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>