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Details for Generic Name: hydrochlorothiazide; valsartan

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Hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Alembic Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Watson Labs Inc, and is included in eight NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-one drug master file entries for hydrochlorothiazide; valsartan. Nine suppliers are listed for this compound.

Summary for Generic Name: hydrochlorothiazide; valsartan

Tradenames:2
Patents:1
Applicants:8
NDAs:8
Drug Master File Entries: see list31
Suppliers: see list9

Pharmacology for Ingredient: hydrochlorothiazide; valsartan

Clinical Trials for: hydrochlorothiazide; valsartan

Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)
Status: Completed Condition: Healthy Normotensive Participants

Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide
Status: Completed Condition: Healthy Normotensive Participants

Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Status: Completed Condition: Hypertension

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818Apr 28, 2006RXYes6,294,197*PED<disabled>Y<disabled>
Mylan Pharms Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL078020Sep 21, 2012RXNo<disabled><disabled>
Apotex Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL203026Mar 21, 2013RXNo<disabled><disabled>
Aurobindo Pharma Ltd
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL202519Mar 21, 2013RXNo<disabled><disabled>
Alembic Ltd
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL201662Mar 21, 2013RXNo<disabled><disabled>
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