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 - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "5dfbbf17-05c0-441d-af66-7a66072f4ae4",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<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>"
  },
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
        "code" : "32P10",
        "display" : "Product Description and Composition of the Drug Product"
      }
    ]
  },
  "date" : "2023-12-09T07:12:23.537Z",
  "author" : [
    {
      "reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
    }
  ],
  "title" : "eCTD Product Description and Composition for Example1Drug",
  "section" : [
    {
      "title" : "Product Description for Example1Drug",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32P11",
            "display" : "Product Description"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc"
        }
      ]
    },
    {
      "title" : "Product Composition for Example1Drug",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32P12",
            "display" : "Product Composition"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149"
        }
      ]
    },
    {
      "title" : "Container Closure Description for Example1Drug",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
            "code" : "32P13",
            "display" : "Product Container Closure Description"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "urn:uuid:77ad6922-9c59-43d1-93cb-29d063cc2e8c"
        }
      ]
    }
  ]
}