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Ganciclovir - Generic Drug Details

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

There are twenty-three drug master file entries for ganciclovir. Two suppliers are listed for this compound.

Summary for Generic Name: ganciclovir

Tradenames:5
Patents:0
Applicants:6
NDAs:8
Drug Master File Entries: see list23
Suppliers / Packaging: see list2
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 Product Substance Delist Req. Exclusivity Expiration
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 1994DISCNNo<disabled><disabled>
Fresenius Kabi Usa
GANCICLOVIR
ganciclovir sodium
INJECTABLE;INJECTION090658-001Jun 21, 2010RXNo<disabled><disabled>
Eurohlth Intl Sarl
GANCICLOVIR SODIUM
ganciclovir sodium
INJECTABLE;INJECTION076222-001Jul 16, 2003DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ganciclovir

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 19974,642,346<disabled>
Bausch And Lomb
VITRASERT
ganciclovir
IMPLANT;IMPLANTATION020569-001Mar 4, 19965,378,475<disabled>
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 19944,355,032<disabled>
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