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: 6248d2ea-c9e0-4280-9beb-08b7041071c2

Generated Narrative: MedicinalProductDefinition 6248d2ea-c9e0-4280-9beb-08b7041071c2

identifier: AmphetamineSalt_1

description:

An uncoated tablet containing amphetamine sulfate

combinedPharmaceuticalDoseForm: TABLET

route: ORAL

Impurities

-Reference
*Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000
*Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000
*Bundle: identifier = UUID:a7a2d35b-5d9d-4a8c-b012-d04a07662c0a; type = document; timestamp = 2024-07-16 10:15:00+0000

name

productName: AMPHETAMINE SULFATE 10mg, DEXTROAMPHETAMINE SULFATE 10mg

type: Non-Proprietary

part

part: AMPHETAMINE SULFATE

type: scientific name

part

part: 10mg

type: AMPHETAMINE SULFATE

part

part: DEXTROAMPHETAMINE SULFATE

type: scientific name

part

part: 10mg

type: DEXTROAMPHETAMINE SULFATE