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: Batch Formula Drug Product Identification

Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c

identifier: Oxazepam-Propranolol-BatchFormula-Identification

combinedPharmaceuticalDoseForm: LIQUID

route: ORAL

comprisedOf: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

name

productName: ATOMOXETINE HYDROCHLORIDE 1mg

type: Non-Proprietary

part

part: ATOMOXETINE HYDROCHLORIDE

type: scientific name

part

part: 1mg

type: ATOMOXETINE HYDROCHLORIDE