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Details for New Drug Application (NDA): 021400

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NDA 021400 describes LEVITRA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the LEVITRA profile page.

The generic ingredient in LEVITRA 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: 021400

Tradename:
LEVITRA
Applicant:
Bayer Hlthcare
Ingredient:
vardenafil hydrochloride
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 021400

Suppliers and Packaging for NDA: 021400

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVITRA
vardenafil hydrochloride
TABLET;ORAL 021400 NDA GlaxoSmithKline LLC 0173-0828 0173-0828-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0173-0828-13)
LEVITRA
vardenafil hydrochloride
TABLET;ORAL 021400 NDA GlaxoSmithKline LLC 0173-0829 0173-0829-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0173-0829-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 19, 2003TE:ABRLD:No
Patent:8,841,446Patent Expiration:Jul 3, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:6,362,178Patent Expiration:Oct 31, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ERECTILE DYSFUNCTION
Patent:7,696,206Patent Expiration:Oct 31, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use: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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