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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 205536


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NDA 205536 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 205536
Tradename:VALSARTAN
Applicant:Alkem Labs Ltd
Ingredient:valsartan
Patents:0
Pharmacology for NDA: 205536
Medical Subject Heading (MeSH) Categories for 205536
Suppliers and Packaging for NDA: 205536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 205536 ANDA American Health Packaging 60687-612 60687-612-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-612-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-612-11)
VALSARTAN valsartan TABLET;ORAL 205536 ANDA American Health Packaging 60687-623 60687-623-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-623-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-623-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Mar 12, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Mar 12, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Mar 12, 2019TE:ABRLD:No

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