Last Updated: November 13, 2026

Details for New Drug Application (NDA): 205646

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NDA 205646 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 205646

Tradename:	TOLVAPTAN
Applicant:	Hetero Labs Ltd V
Ingredient:	tolvaptan
Patents:	0

Pharmacology for NDA: 205646

Mechanism of Action	Vasopressin V2 Receptor Antagonists

Suppliers and Packaging for NDA: 205646

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOLVAPTAN	tolvaptan	TABLET;ORAL	205646	ANDA	Camber Pharmaceuticals, Inc.	31722-868	31722-868-01	10 BLISTER PACK in 1 CARTON (31722-868-01) / 10 TABLET in 1 BLISTER PACK
TOLVAPTAN	tolvaptan	TABLET;ORAL	205646	ANDA	Camber Pharmaceuticals, Inc.	31722-868	31722-868-02	10 BLISTER PACK in 1 CARTON (31722-868-02) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jul 16, 2021	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Sep 6, 2022	TE:	AB1	RLD:	No

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