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Last Updated: September 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204011


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NDA 204011 describes VALSARTAN, which is a drug marketed by Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Square Pharms Ltd, Torrent, Unichem, Watson Labs Inc, Apotex Inc, Mylan Pharms Inc, Watson Labs Teva, and Zydus Pharms, and is included in twenty-five NDAs. It is available from twenty-one suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 204011
Tradename:VALSARTAN
Applicant:Amneal Pharms
Ingredient:valsartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204011
Medical Subject Heading (MeSH) Categories for 204011
Suppliers and Packaging for NDA: 204011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 204011 ANDA AvKARE 42291-856 42291-856-30 30 TABLET in 1 BOTTLE (42291-856-30)
VALSARTAN valsartan TABLET;ORAL 204011 ANDA AvKARE 42291-857 42291-857-90 90 TABLET in 1 BOTTLE (42291-857-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 11, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 11, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jan 11, 2016TE:ABRLD:No

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