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Generated: November 21, 2018

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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 202276
Tradename:STENDRA
Applicant:Metuchen Pharms
Ingredient:avanafil
Patents:2
Generic Entry Opportunity Date for 202276
Generic Entry Date for 202276*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Mist Pharmaceuticals, LLC 76299-320 76299-320-85 30 TABLET in 1 BOTTLE (76299-320-85)
STENDRA avanafil TABLET;ORAL 202276 NDA Mist Pharmaceuticals, LLC 76299-320 76299-320-88 100 TABLET in 1 BOTTLE (76299-320-88)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 27, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION
Patent:➤ Try a Free TrialPatent Expiration:May 5, 2023Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 27, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION

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