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Details for Generic Name: ganciclovir

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Ganciclovir is the generic ingredient in five branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Fresenius Kabi Usa, Luitpold, and Eurohlth Intl Sarl, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: ganciclovir

Drug Master File Entries: see list21
Suppliers: see list1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Clinical Trials for: ganciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
ganciclovir sodium
INJECTABLE; INJECTION076222-001Jul 16, 2003RXNo<disabled><disabled>
Roche Palo
CAPSULE; ORAL020460-002Dec 12, 1997DISCNNo<disabled><disabled>
Roche Palo
CAPSULE; ORAL020460-001Dec 22, 1994DISCNNo<disabled><disabled>
CAPSULE; ORAL076457-002Jun 27, 2003RXYes<disabled><disabled>
CAPSULE; ORAL076457-001Jun 27, 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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