APPLICATION
ANDA090242
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-17
LATEST ACTION
2024-09-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval), Prescription
Products
GEMCITABINE HYDROCHLORIDENone (Tentative Approval)
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDENone (Tentative Approval)
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-24Labeling · Supplement 8 · standardAP
2024-09-12Labeling · Supplement 4 · standardAP
2011-05-17OriginalAP
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.