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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204204

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NDA 204204 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 204204

Tradename:	GANCICLOVIR SODIUM
Applicant:	Slate Run Pharma
Ingredient:	ganciclovir sodium
Patents:	0

Pharmacology for NDA: 204204

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 204204

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204	ANDA	Slate Run Pharmaceuticals, LLC	70436-089	70436-089-55	25 VIAL in 1 CARTON (70436-089-55) / 10 mL in 1 VIAL
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204	ANDA	Slate Run Pharmaceuticals, LLC	70436-231	70436-231-55	25 VIAL in 1 CARTON (70436-231-55) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Nov 8, 2018	TE:	AP	RLD:	No

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