APPLICATION
ANDA207645
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-08
LATEST ACTION
2024-02-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GANCICLOVIR SODIUMPrescription
GANCICLOVIR SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-02-15Labeling · Supplement 2 · standardAP
2020-05-18Labeling · Supplement 1 · standardAP
2017-12-08UNKNOWN · 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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