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Details for New Drug Application (NDA): 202276

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NDA 202276 describes STENDRA, which is a drug marketed by Metuchen Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STENDRA profile page.

The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the avanafil profile page.

Summary for NDA: 202276

Tradename:
STENDRA
Applicant:
Metuchen Pharms
Ingredient:
avanafil
Patents:2

Pharmacology for NDA: 202276

Suppliers and Packaging for NDA: 202276

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STENDRA
avanafil
TABLET;ORAL 202276 NDA VIVUS, Inc. 62541-301 62541-301-01 100 TABLET in 1 BOTTLE, PLASTIC (62541-301-01)
STENDRA
avanafil
TABLET;ORAL 202276 NDA VIVUS, Inc. 62541-301 62541-301-30 30 TABLET in 1 BOTTLE, PLASTIC (62541-301-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 27, 2012TE:RLD:No
Patent:7,501,409Patent Expiration:May 5, 2023Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Apr 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 17, 2017
Regulatory Exclusivity Use:REVISED DOSING SCHEDULE TO ADMINISTER AVANAFIL 15 MINUTES PRIOR TO SEXUAL ACTIVITY


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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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