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Details for Generic Name: ganciclovir sodium

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Ganciclovir sodium is the generic ingredient in two branded drugs marketed by Roche Palo, Fresenius Kabi Usa, Luitpold, and Eurohlth Intl Sarl, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for ganciclovir sodium. One supplier is listed for this compound.

Summary for Generic Name: ganciclovir sodium

Drug Master File Entries: see list22
Suppliers / Packaging: see list1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ganciclovir sodium

Clinical Trials for: ganciclovir sodium

Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
Status: Recruiting Condition: Cytomegalovirus Anterior Segment Infection; Anterior Uveitis; Endotheliitis

Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
Status: Completed Condition: Infection in Solid Organ Transplant Recipients

Study of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure
Status: Recruiting Condition: Acute Lung Injury; Acute Respiratory Distress Syndrome; Respiratory Failure

A Placebo Controlled Comparison of Topical Zirgan Versus Genteal Gel for the Treatment of Adenovirus Conjunctivitis
Status: Recruiting Condition: Keratoconjunctivitis Due to Adenovirus; Viral Shedding

Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
Status: Not yet recruiting Condition: Conjunctivitis; Adenovirus.

Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Status: Terminated Condition: Allogeneic Stem Cell Transplantation

Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis
Status: Recruiting Condition: Herpes Zoster Keratitis

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Roche Palo
ganciclovir sodium
INJECTABLE; INJECTION019661-001Jun 23, 1989RXYes<disabled><disabled>
ganciclovir sodium
INJECTABLE; INJECTION076222-001Jul 16, 2003RXNo<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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