Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

: EctdComposition32P10 for 2 layer tablet - XML Representation

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<Composition xmlns="http://hl7.org/fhir">
  <id value="5dfbbf17-05c0-441d-af66-7a66072f4ae4"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Composition</b><a name="5dfbbf17-05c0-441d-af66-7a66072f4ae4"> </a><a name="hc5dfbbf17-05c0-441d-af66-7a66072f4ae4"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition &quot;5dfbbf17-05c0-441d-af66-7a66072f4ae4&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ectd-composition-32p10.html">eCTD Product Description and Composition</a></p></div><p><b>status</b>: final</p><p><b>type</b>: Product Description and Composition of the Drug Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-comp-section-types.html">Code System PQCMC Comp Section Types</a>#32P10)</span></p><p><b>date</b>: 2023-12-09 07:12:23+0000</p><p><b>author</b>: <a href="Bundle-4a7e17c1-a611-4cc7-9a71-8005a8b427ab.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a">urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</a></p><p><b>title</b>: eCTD Product Description and Composition for Example1Drug</p></div>
  </text>
  <status value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
      <code value="32P10"/>
      <display
               value="Product Description and Composition of the Drug Product"/>
    </coding>
  </type>
  <date value="2023-12-09T07:12:23.537Z"/>
  <author>
    <reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
  </author>
  <title value="eCTD Product Description and Composition for Example1Drug"/>
  <section>
    <title value="Product Description for Example1Drug"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32P11"/>
        <display value="Product Description"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc"/>
    </entry>
  </section>
  <section>
    <title value="Product Composition for Example1Drug"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32P12"/>
        <display value="Product Composition"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149"/>
    </entry>
  </section>
  <section>
    <title value="Container Closure Description for Example1Drug"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
        <code value="32P13"/>
        <display value="Product Container Closure Description"/>
      </coding>
    </code>
    <entry>
      <reference value="urn:uuid:77ad6922-9c59-43d1-93cb-29d063cc2e8c"/>
    </entry>
  </section>
</Composition>