APPLICATION
ANDA204950
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-06
LATEST ACTION
2020-06-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GANCICLOVIR SODIUMPrescription
GANCICLOVIR SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-06-08Labeling · Supplement 2 · standardAP
2016-12-06UNKNOWN · 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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