APPLICATION
ANDA207575
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-22
LATEST ACTION
2024-09-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
GEMCITABINE HYDROCHLORIDEPrescription
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-09-24Labeling · Supplement 2 · standardAP
2019-10-03Labeling · Supplement 1 · standardAP
2019-02-22UNKNOWN · 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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