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 is one patent 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. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.

Summary for 202276

Tradename:	STENDRA
Applicant:	Metuchen Pharms
Ingredient:	avanafil
Patents:	1

Pharmacology for NDA: 202276

Mechanism of Action	Phosphodiesterase 5 Inhibitors

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	Metuchen Pharmaceuticals, LLC	72384-751	72384-751-30	30 TABLET in 1 BOTTLE (72384-751-30)
STENDRA	avanafil	TABLET;ORAL	202276	NDA	Metuchen Pharmaceuticals, LLC	72384-752	72384-752-30	30 TABLET in 1 BOTTLE (72384-752-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 27, 2012	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 18, 2025
Regulatory Exclusivity Use:	REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY
Patent:	6,656,935	Patent Expiration:	Apr 27, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ERECTILE DYSFUNCTION

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 27, 2012	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 18, 2025
Regulatory Exclusivity Use:	REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY

Expired US Patents for NDA 202276

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	7,501,409	⤷ Subscribe
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	7,501,409	⤷ Subscribe
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	7,501,409	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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