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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090658

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NDA 090658 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Onesource Specialty, Ph Health, Pharmascience Inc, and Slate Run Pharma, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the GANCICLOVIR SODIUM profile page.

The generic ingredient in GANCICLOVIR SODIUM is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

Summary for 090658

Tradename:	GANCICLOVIR SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	ganciclovir sodium
Patents:	0

Pharmacology for NDA: 090658

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 090658

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	090658	ANDA	Fresenius Kabi USA, LLC	63323-315	63323-315-94	25 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41)
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	090658	ANDA	Fresenius Kabi USA, LLC	63323-315	63323-315-10	25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 21, 2010	TE:	AP	RLD:	No

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