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

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chubb
Healthtrust
Covington
QuintilesIMS
Daiichi Sankyo
Colorcon
Accenture
Farmers Insurance

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201662

« Back to Dashboard

NDA 201662 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Watson Labs Teva, and is included in eight NDAs. It is available from twenty-three suppliers. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 201662
Tradename:VALSARTAN AND HYDROCHLOROTHIAZIDE
Applicant:Alembic Pharms Ltd
Ingredient:hydrochlorothiazide; valsartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201662
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 201662
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662 ANDA Alembic Pharmaceuticals Limited 46708-453 N 46708-453-10
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662 ANDA Alembic Pharmaceuticals Limited 46708-453 N 46708-453-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Mar 21, 2013TE: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:

Baxter
Dow
McKinsey
Accenture
Merck
Colorcon
QuintilesIMS
UBS
Cerilliant

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.