Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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 89676a69-1fe7-422c-ab00-92abe4ef6ea9

identifier: Example2BeadDrug

combinedPharmaceuticalDoseForm: CAPSULE

route: ORAL

name

productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg

type: Non-Proprietary

part

part: OXAZEPAM

type: scientific name

part

part: 30mg

type: OXAZEPAM

part

part: PROPRANOLOL HYDROCHLORIDE

type: scientific name

part

part: 60mg

type: PROPRANOLOL HYDROCHLORIDE