Orange Book product · Brand (NDA)

STAXYN

VARDENAFIL HYDROCHLORIDE

Brand (NDA)NDA 200179DISCN BAYER HLTHCARE

Jun 17, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 17, 2010
16 yr 3 mo ago
Today
Patent 8613950 expires
Listed drug product patent expiration.
Dec 23, 2028
in 2 yr 7 mo

Active ingredient

VARDENAFIL HYDROCHLORIDE

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 200179

Product number

001

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
8613950	Dec 23, 2028	in 2 yr 7 mo	Product