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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 two suppliers. There are three patents 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 five drug master file entries for this compound. Six suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for NDA: 200179

Tradename:
STAXYN
Applicant:
Bayer Hlthcare
Ingredient:
vardenafil hydrochloride
Patents:3
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
STAXYN
vardenafil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 200179 NDA GlaxoSmithKline LLC 0173-0822 0173-0822-14 10 BLISTER PACK in 1 BOX (0173-0822-14) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Jun 17, 2010TE:ABRLD:Yes
Patent:8,613,950Patent Expiration:Dec 23, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:6,362,178Patent Expiration:Oct 31, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION
Patent:7,696,206Patent Expiration:Oct 31, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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