Last Updated: November 10, 2026

Details for New Drug Application (NDA): 216949

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NDA 216949 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 216949

Tradename:	TOLVAPTAN
Applicant:	Msn
Ingredient:	tolvaptan
Patents:	0

Pharmacology for NDA: 216949

Mechanism of Action	Vasopressin V2 Receptor Antagonists

Suppliers and Packaging for NDA: 216949

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOLVAPTAN	tolvaptan	TABLET;ORAL	216949	ANDA	Novadoz Pharmaceuticals LLC	72205-130	72205-130-11	1 BLISTER PACK in 1 CARTON (72205-130-11) / 10 TABLET in 1 BLISTER PACK
TOLVAPTAN	tolvaptan	TABLET;ORAL	216949	ANDA	Novadoz Pharmaceuticals LLC	72205-131	72205-131-11	1 BLISTER PACK in 1 CARTON (72205-131-11) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 21, 2023	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jun 21, 2023	TE:	AB1	RLD:	No

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