Details for New Drug Application (NDA): 200179

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NDA 200179 describes STAXYN, which is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the STAXYN profile page.

The generic ingredient in STAXYN 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 200179

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 17, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 23, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 200179

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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