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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

Drug Master File Entries: see list31
Suppliers: see list9
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydrochlorothiazide; valsartan

Clinical Trials for: hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Ltd
hydrochlorothiazide; valsartan
TABLET;ORAL201662-005Mar 21, 2013RXNo<disabled><disabled>
Alembic Ltd
hydrochlorothiazide; valsartan
TABLET;ORAL201662-002Mar 21, 2013RXNo<disabled><disabled>
Mylan Pharms Inc
hydrochlorothiazide; valsartan
TABLET;ORAL078020-001Sep 21, 2012RXNo<disabled><disabled>
Watson Labs Inc
hydrochlorothiazide; valsartan
TABLET;ORAL091519-004Mar 21, 2013RXNo<disabled><disabled>
hydrochlorothiazide; valsartan
TABLET;ORAL020818-005Apr 28, 2006RXYes6,294,197*PED<disabled>Y<disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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