Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205988

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NDA 205988 describes VARDENAFIL HYDROCHLORIDE, which is a drug marketed by Alembic, Macleods Pharms, 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for 205988

Tradename:	VARDENAFIL HYDROCHLORIDE
Applicant:	Macleods Pharms
Ingredient:	vardenafil hydrochloride
Patents:	0

Pharmacology for NDA: 205988

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Suppliers and Packaging for NDA: 205988

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	205988	ANDA	Macleods Pharmaceuticals Limited	33342-203	33342-203-37	1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Mar 10, 2020	TE:	AB	RLD:	No

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