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 SubstanceDefinition: Example SubstanceDefinition- ATOMOXETINE HYDROCHLORIDE

Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058

classification: Chemical

grade: USP-NF

manufacturer: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

Codes

-Code
*57WVB6I2W0

Names

-NameTypePreferred
*ATOMOXETINE HYDROCHLORIDEGSRS Preferred Termtrue