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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 211891


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NDA 211891 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 211891
Tradename:TOLVAPTAN
Applicant:Alkem Labs Ltd
Ingredient:tolvaptan
Patents:0
Pharmacology for NDA: 211891
Mechanism of ActionVasopressin V2 Receptor Antagonists
Suppliers and Packaging for NDA: 211891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLVAPTAN tolvaptan TABLET;ORAL 211891 ANDA Ascend Laboratories, LLC 67877-635 67877-635-01 100 TABLET in 1 BOTTLE (67877-635-01)
TOLVAPTAN tolvaptan TABLET;ORAL 211891 ANDA Ascend Laboratories, LLC 67877-635 67877-635-02 10 TABLET in 1 BOTTLE (67877-635-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 19, 2020TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:May 19, 2020TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Sep 6, 2022TE:AB1RLD:No

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Preferred Citation:

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