APPLICATION
ANDA202063
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-11
LATEST ACTION
2019-11-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2019-11-14Labeling · Supplement 9 · standardAP
2019-11-14Labeling · Supplement 7 · standardAP
2019-11-14Labeling · Supplement 8 · standardAP
2015-11-27Labeling · Supplement 3 · standardAP
2015-11-27Labeling · Supplement 1 · standardAP
2015-11-27Labeling · Supplement 4 · 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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