APPLICATION
ANDA204549
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-11
LATEST ACTION
2026-07-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEDiscontinued
GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) · INJECTABLE · INJECTION
Approval history
2026-07-17Labeling · Supplement 5 · standardAP
2020-06-23Labeling · Supplement 3 · standardAP
2019-05-03Labeling · Supplement 2 · standardAP
2016-04-11UNKNOWN · 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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