APPLICATION
ANDA076222
TYPE
ANDA
ORIGINAL APPROVAL
2003-07-16
LATEST ACTION
2025-03-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GANCICLOVIR SODIUMPrescription
GANCICLOVIR SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-03-27Labeling · Supplement 7 · standardAP
2021-05-05Labeling · Supplement 6 · standardAP
2009-02-26Labeling · Supplement 2AP
2003-07-16OriginalAP
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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