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

Example MedicinalProductDefinition: A DrugProductDescription for a multilayer product

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "5772a6f2-cde1-4903-bfcf-1639340205cc"

Profile: Drug Product Description

description: A tablet consisting of two layers where one provides immediate release and of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.

combinedPharmaceuticalDoseForm: TABLET, MULTILAYER (PQ-CMC-FDA Temporary Codes#C42964)

route: ORAL (PQ-CMC-FDA Temporary Codes#C38288)

name

productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: ASPIRIN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 200mg

type: strength name (EntityNamePartQualifierR2#STR)

part

part: ACETAMINOPHEN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 300mg

type: strength name (EntityNamePartQualifierR2#STR)