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Generated: September 23, 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 NDA: 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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;ORAL020460-002Dec 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
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;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
UBS
Daiichi Sankyo
Medtronic
Argus Health
Teva
Moodys
Colorcon
Novartis

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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