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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 203536


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NDA 203536 describes VALSARTAN, which is a drug marketed by Novitium Pharma, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Sciegen Pharms Inc, Square Pharms, Torrent, Unichem, Watson Labs Inc, Apotex Inc, Mylan Pharms Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in twenty-nine NDAs. It is available from thirty 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. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 203536
Tradename:VALSARTAN
Applicant:Jubilant Generics
Ingredient:valsartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203536
Medical Subject Heading (MeSH) Categories for 203536
Suppliers and Packaging for NDA: 203536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 203536 ANDA Medsource Pharmaceuticals 45865-101 45865-101-60 60 TABLET in 1 BOTTLE (45865-101-60)
VALSARTAN valsartan TABLET;ORAL 203536 ANDA A-S Medication Solutions 50090-5190 50090-5190-0 30 TABLET in 1 BOTTLE (50090-5190-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 5, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 5, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jan 5, 2015TE:ABRLD:No

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