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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020460

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NDA 020460 describes CYTOVENE, which is a drug marketed by Roche Palo and is included in two NDAs. It is available from one supplier. Additional details are available on the CYTOVENE profile page.

The generic ingredient in CYTOVENE is ganciclovir sodium. There are twenty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

Summary for 020460

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 22, 1994TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 12, 1997TE:RLD:Yes

Expired Orange Book Patents for NDA: 020460

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 1994► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 1994► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 1994► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 1994► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Queensland Health
Teva
Merck
Fish and Richardson
AstraZeneca
Citi
Covington
Federal Trade Commission

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