Last Updated: June 9, 2026

Details for New Drug Application (NDA): 218897


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NDA 218897 describes VALSARTAN, which is a drug marketed by Novitium Pharma, Rubicon, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Laurus, Lupin, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Renata, Sciegen Pharms, Square Pharms Plc, Torrent, Unichem, Watson Labs Inc, Zydus Lifesciences, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-four NDAs. It is available from thirty-three 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. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 218897
Tradename:VALSARTAN
Applicant:Laurus
Ingredient:valsartan
Patents:0
Pharmacology for NDA: 218897
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 218897
Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents
Suppliers and Packaging for NDA: 218897
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 218897 ANDA Laurus Labs Limited 42385-989 42385-989-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-989-05)
VALSARTAN valsartan TABLET;ORAL 218897 ANDA Laurus Labs Limited 42385-989 42385-989-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-989-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 21, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Apr 21, 2026TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Apr 21, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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