Last Updated: September 24, 2026

Details for New Drug Application (NDA): 090658

✉ Email this page to a colleague

« Back to Dashboard

NDA 090658 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 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	63323-315-10	25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01)
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)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.