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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 205347


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NDA 205347 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, Zenara, Zydus Lifesciences, Apotex Inc, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-one NDAs. It is available from thirty-four 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 205347
Tradename:VALSARTAN
Applicant:Square Pharms
Ingredient:valsartan
Patents:0
Pharmacology for NDA: 205347
Medical Subject Heading (MeSH) Categories for 205347
Suppliers and Packaging for NDA: 205347
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 205347 ANDA Marlex Pharmaceuticals, Inc. 10135-768 10135-768-30 30 TABLET in 1 BOTTLE (10135-768-30)
VALSARTAN valsartan TABLET;ORAL 205347 ANDA Marlex Pharmaceuticals, Inc. 10135-769 10135-769-90 90 TABLET in 1 BOTTLE (10135-769-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 9, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Apr 9, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Apr 9, 2018TE:ABRLD:No

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