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Last Updated: July 7, 2020

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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. It is available from one supplier. 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 200179
Suppliers and Packaging for NDA: 200179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STAXYN vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 200179 NDA GlaxoSmithKline LLC 0173-0822 0173-0822-04 1 BLISTER PACK in 1 BOX (0173-0822-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 200179
Tradename Dosage Ingredient NDA Submissiondate
STAXYN TABLET, ORALLY DISINTEGRATING;ORAL vardenafil hydrochloride 200179 2011-12-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Jun 17, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 23, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 200179

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

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