Details for New Drug Application (NDA): 021400

✉ Email this page to a colleague

NDA 021400 describes LEVITRA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the LEVITRA profile page.

The generic ingredient in LEVITRA 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 021400

Tradename:	LEVITRA
Applicant:	Bayer Hlthcare
Ingredient:	vardenafil hydrochloride
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 19, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 23, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 19, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 23, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 19, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 23, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Expired US Patents for NDA 021400

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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. 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.