Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

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: 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)