APPLICATION
ANDA079183
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-15
LATEST ACTION
2024-09-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-24Labeling · Supplement 14 · standardAP
2019-10-03Labeling · Supplement 8 · standardAP
2019-10-03Labeling · Supplement 7 · standardAP
2016-11-17Labeling · Supplement 4 · standardAP
2016-11-17Labeling · Supplement 5 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.