Last Updated: September 24, 2026

Details for New Drug Application (NDA): 076222

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NDA 076222 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 076222

Tradename:	GANCICLOVIR SODIUM
Applicant:	Hikma
Ingredient:	ganciclovir sodium
Patents:	0

Pharmacology for NDA: 076222

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 076222

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	076222	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9299	0143-9299-10	10 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jul 16, 2003	TE:	AP	RLD:	No

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