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

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Moodys
Healthtrust
Mallinckrodt
Medtronic
Cipla
Farmers Insurance
US Army
Daiichi Sankyo

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200790

« Back to Dashboard

NDA 200790 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 twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 200790
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Endo Pharms Inc
Ingredient:valganciclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 200790
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 200790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 200790 ANDA Qualitest Pharmaceuticals 0603-6330 N 0603-6330-20
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 200790 ANDA AvKARE, Inc. 42291-875 N 42291-875-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Nov 4, 2014TE: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:

Johnson and Johnson
Mallinckrodt
UBS
Citi
QuintilesIMS
Covington
Healthtrust
US Department of Justice
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.