Orange Book product · Brand (NDA)

LEVITRA

VARDENAFIL HYDROCHLORIDE

Brand (NDA)NDA 021400DISCN BAYER HLTHCARE

Aug 19, 2003

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 19, 2003
23 yr 2 mo ago
Today
Patent 8273876 expires
Listed method-of-use patent (U-1288) expiration.
Jul 23, 2027
in 1 yr 1 mo

Active ingredient

VARDENAFIL HYDROCHLORIDE

Strength

EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 021400

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8273876	Jul 23, 2027	in 1 yr 1 mo	U-1288