APPLICATION
NDA219920
TYPE
NDA
ORIGINAL APPROVAL
2025-06-27
LATEST ACTION
2025-06-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued
Products
AVGEMSI · ReferencePrescription
GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) · SOLUTION · INTRAVENOUS
AVGEMSI · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) · SOLUTION · INTRAVENOUS
AVGEMSI · ReferencePrescription
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-06-27Type 5 - New Formulation or New Manufacturer · Supplement 1 · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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