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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Fish and Richardson
US Department of Justice
Chubb
Deloitte
McKesson
Cipla
Covington
Johnson and Johnson

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091114

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NDA 091114 describes FAMCICLOVIR, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Teva Pharms, and West-ward Pharms Int, and is included in eight NDAs. It is available from nineteen suppliers. Additional details are available on the FAMCICLOVIR profile page.

The generic ingredient in FAMCICLOVIR is famciclovir. There are eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the famciclovir profile page.
Summary for 091114
Tradename:FAMCICLOVIR
Applicant:Aurobindo Pharma Ltd
Ingredient:famciclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 091114
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 091114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMCICLOVIR famciclovir TABLET;ORAL 091114 ANDA NorthStar Rx LLC 16714-300 N 16714-300-01
FAMCICLOVIR famciclovir TABLET;ORAL 091114 ANDA NorthStar Rx LLC 16714-304 N 16714-304-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Mar 21, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 21, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 21, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
Daiichi Sankyo
US Department of Justice
Fish and Richardson
Express Scripts
UBS
Cantor Fitzgerald
Argus Health

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