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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218381


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NDA 218381 describes TOLVAPTAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd V, Lupin Ltd, MSN, and Ph Health, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the TOLVAPTAN profile page.

The generic ingredient in TOLVAPTAN is tolvaptan. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 218381
Tradename:TOLVAPTAN
Applicant:Apotex
Ingredient:tolvaptan
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Nov 10, 2025TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Nov 10, 2025TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Nov 10, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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