You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 14, 2025

Details for New Drug Application (NDA): 208324

✉ Email this page to a colleague

« Back to Dashboard

NDA 208324 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 208324

Tradename:	VARDENAFIL HYDROCHLORIDE
Applicant:	Alembic
Ingredient:	vardenafil hydrochloride
Patents:	0

Pharmacology for NDA: 208324

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Suppliers and Packaging for NDA: 208324

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	208324	ANDA	Alembic Pharmaceuticals Limited	46708-235	46708-235-04	4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)
VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	208324	ANDA	Alembic Pharmaceuticals Inc.	62332-235	62332-235-04	4 BLISTER PACK in 1 CARTON (62332-235-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Nov 16, 2018	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.