Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220147

✉ Email this page to a colleague

« Back to Dashboard

NDA 220147 describes TOLVAPTAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd V, Lupin, MSN, Ph Health, and Teva Pharms Inc, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the TOLVAPTAN profile page.

The generic ingredient in TOLVAPTAN is tolvaptan. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.

Summary for 220147

Tradename:	TOLVAPTAN
Applicant:	Alkem Labs Ltd
Ingredient:	tolvaptan
Patents:	0

Pharmacology for NDA: 220147

Mechanism of Action	Vasopressin V2 Receptor Antagonists

Suppliers and Packaging for NDA: 220147

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOLVAPTAN	tolvaptan	TABLET;ORAL	220147	ANDA	Ascend Laboratories, LLC	67877-915	67877-915-30	30 TABLET in 1 BOTTLE (67877-915-30)
TOLVAPTAN	tolvaptan	TABLET;ORAL	220147	ANDA	Ascend Laboratories, LLC	67877-916	67877-916-30	30 TABLET in 1 BOTTLE (67877-916-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Apr 21, 2026	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Apr 21, 2026	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	45MG
Approval Date:	Apr 21, 2026	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.