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: ddd3abad-347c-4d2f-95f3-dd804e250502

Generated Narrative: MedicinalProductDefinition ddd3abad-347c-4d2f-95f3-dd804e250502

identifier: TabletCoatedBeadsCoatedAll

description:

A drug product composed of one type of bead with two coatings inside a coated tablet

combinedPharmaceuticalDoseForm: TABLET, MULTILAYER

route: ORAL

Impurities

-Reference
*Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000
*Bundle: identifier = UUID:2b738e27-de1f-4f63-8d91-c8860089d2a1; type = document; timestamp = 2024-04-24 01:12:07+0000

name

productName: LEVOTHYROXINE SODIUM ANHYDROUS 125mg

type: Non-Proprietary

part

part: LEVOTHYROXINE SODIUM ANHYDROUS

type: scientific name

part

part: 125mg

type: LEVOTHYROXINE SODIUM ANHYDROUS