APPLICATION
ANDA079160
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-25
LATEST ACTION
2024-09-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-24Labeling · Supplement 13 · standardAP
2020-02-28Labeling · Supplement 11 · standardAP
2019-05-01Labeling · Supplement 10 · standardAP
2019-05-01Labeling · Supplement 9 · standardAP
2016-07-28Manufacturing (CMC) · Supplement 3AP
2015-05-07Manufacturing (CMC) · Supplement 2AP
2015-04-02Labeling · Supplement 6 · standardAP
2014-07-08Labeling · Supplement 5 · standardAP
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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