Last Updated: September 24, 2026

Details for New Drug Application (NDA): 207645

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NDA 207645 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly, Hikma, Onesource Specialty, Ph Health, and Pharmascience Inc, 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

Summary for 207645

Tradename:	GANCICLOVIR SODIUM
Applicant:	Pharmascience Inc
Ingredient:	ganciclovir sodium
Patents:	0

Pharmacology for NDA: 207645

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 207645

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	207645	ANDA	Sagent Pharmaceuticals	25021-185	25021-185-10	25 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIAL
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	207645	ANDA	Pharmascience Inc.	51817-171	51817-171-01	25 VIAL in 1 CARTON (51817-171-01) / 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:	Dec 8, 2017	TE:	AP	RLD:	No

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