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FDA ANDA · ANDA090658

GANCICLOVIR

ganciclovir sodium

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA090658
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-21
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 4 · standardAP
2020-06-08Labeling · Supplement 3 · standardAP
2010-06-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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