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Ganciclovir sodium - Generic Drug Details

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

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

Summary for Generic Name: ganciclovir sodium

Tradenames:3
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list23
Suppliers / Packaging: see list3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ganciclovir sodium

Clinical Trials for: ganciclovir sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eurohlth Intl Sarl
GANCICLOVIR SODIUM
ganciclovir sodium
INJECTABLE;INJECTION076222-001Jul 16, 2003DISCNNo<disabled><disabled>
Fresenius Kabi Usa
GANCICLOVIR
ganciclovir sodium
INJECTABLE;INJECTION090658-001Jun 21, 2010RXNo<disabled><disabled>
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 1989RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ganciclovir sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 19894,507,305<disabled>
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 19894,355,032<disabled>
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 19894,423,050<disabled>
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