Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Example MedicinalProductDefinition: drug product for specification

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "89676a69-1fe7-422c-ab00-92abe4ef6ea9"

Profile: Routine Drug Product

identifier: Example2BeadDrug

combinedPharmaceuticalDoseForm: CAPSULE (PQ-CMC-FDA Temporary Codes#C25158)

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

name

productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg

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

part

part: OXAZEPAM

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 30mg

type: strength name (EntityNamePartQualifierR2#STR)

part

part: PROPRANOLOL HYDROCHLORIDE

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 60mg

type: strength name (EntityNamePartQualifierR2#STR)