Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Citi
Colorcon
Dow
Harvard Business School
McKinsey
Moodys
Novartis
McKesson
Merck
Argus Health

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201022

« Back to Dashboard

NDA 201022 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 201022
Tradename:FAMCICLOVIR
Applicant:Macleods Pharms Ltd
Ingredient:famciclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 201022
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 201022
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMCICLOVIR famciclovir TABLET;ORAL 201022 ANDA Macleods Pharmaceuticals Limited 33342-024 N 33342-024-07
FAMCICLOVIR famciclovir TABLET;ORAL 201022 ANDA Macleods Pharmaceuticals Limited 33342-025 N 33342-025-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Jan 12, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 12, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jan 12, 2012TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
McKinsey
Colorcon
McKesson
QuintilesIMS
Healthtrust
Cerilliant
Moodys

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.

botpot