APPLICATION
ANDA078339
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-25
LATEST ACTION
2024-09-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-24Labeling · Supplement 18 · standardAP
2020-03-04Labeling · Supplement 10 · standardAP
2020-03-04Labeling · Supplement 11 · standardAP
2020-03-04Labeling · Supplement 8 · standardAP
2016-06-23Labeling · Supplement 5 · standardAP
2016-06-23Labeling · Supplement 6 · standardAP
2011-12-05Labeling · Supplement 1AP
2011-07-25OriginalAP
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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