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

Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Moodys
AstraZeneca
Merck
Covington
Express Scripts
Daiichi Sankyo
Johnson and Johnson
Cerilliant

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205220

« Back to Dashboard

NDA 205220 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 205220
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Actavis Labs Fl Inc
Ingredient:valganciclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 205220
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 205220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 205220 ANDA Actavis Pharma, Inc. 0591-2579 N 0591-2579-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Jul 18, 2016TE: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:

Harvard Business School
Johnson and Johnson
Chinese Patent Office
Accenture
Daiichi Sankyo
Chubb
Medtronic
Argus Health
Farmers Insurance

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