APPLICATION
ANDA200145
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 2GM BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-24Labeling · Supplement 15 · standardAP
2020-02-28Labeling · Supplement 12 · standardAP
2019-05-03Labeling · Supplement 11 · standardAP
2019-05-03Labeling · Supplement 10 · standardAP
2015-06-30Labeling · Supplement 6 · standardAP
2015-06-30Labeling · Supplement 4 · standardAP
2015-06-30Labeling · Supplement 3 · standardAP
2015-06-30Labeling · 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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