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: A DrugProductDescription for a multilayer product

Generated Narrative: MedicinalProductDefinition 5772a6f2-cde1-4903-bfcf-1639340205cc

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

route: ORAL

name

productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

type: Non-Proprietary

part

part: ASPIRIN

type: scientific name

part

part: 200mg

type: ASPIRIN

part

part: ACETAMINOPHEN

type: scientific name

part

part: 300mg

type: ACETAMINOPHEN