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Last Updated: December 14, 2019

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Details for New Drug Application (NDA): 021400

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NDA 021400 describes LEVITRA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021400
Suppliers and Packaging for NDA: 021400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVITRA vardenafil hydrochloride TABLET;ORAL 021400 NDA GlaxoSmithKline LLC 0173-0829 0173-0829-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0173-0829-13)
LEVITRA vardenafil hydrochloride TABLET;ORAL 021400 NDA GlaxoSmithKline LLC 0173-0830 0173-0830-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0173-0830-13)
Paragraph IV (Patent) Challenges for 021400
Tradename Dosage Ingredient NDA Submissiondate
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-09-04
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-07-10
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-03-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 19, 2003TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jul 23, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
Patent:  Start TrialPatent Expiration:Jul 3, 2023Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 19, 2003TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jul 23, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Expired US Patents for NDA 021400

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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