Details for New Drug Application (NDA): 211891

NDA 211891 describes TOLVAPTAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN, and is included in five NDAs. It is available from five 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. Six 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 Action

Vasopressin 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:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	May 19, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	May 19, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Sep 6, 2022	TE:	AB	RLD:	No

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