Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Publication Build: This will be filled in by the publication tooling

Example Ingredient: Strength information for the Active Ingredient - acetaminophen

Generated Narrative: Ingredient

Resource Ingredient "7f10a35e-228d-42db-8918-6ccada78454d"

Profile: Drug Product Component

status: draft

role: Active Ingredient (PQ-CMC-FDA Temporary Codes#C82533)

substance

Codes

-Reference
*urn:uuid:fc878c4f-a98c-427c-816b-e03ccdf0e712

Strengths

-ExtensionPresentation[x]TextPresentation
*300 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')/1 [arb'U] (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C75765 = '[arb'U]')300mg