APPLICATION
ANDA209077
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2026-03-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) · INJECTABLE · INJECTION
Approval history
2026-03-13Labeling · Supplement 5 · standardAP
2020-11-04Labeling · Supplement 3 · standardAP
2018-07-20UNKNOWN · Original · 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.
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