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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 210738

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NDA 210738 describes VARDENAFIL HYDROCHLORIDE, which is a drug marketed by Alembic, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the VARDENAFIL HYDROCHLORIDE profile page.

The generic ingredient in VARDENAFIL HYDROCHLORIDE is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for 210738

Tradename:	VARDENAFIL HYDROCHLORIDE
Applicant:	Stevens J
Ingredient:	vardenafil hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Oct 31, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Oct 31, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Oct 31, 2018	TE:		RLD:	No

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