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Last Updated: November 21, 2024

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 ActionPhosphodiesterase 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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 27, 2012TE:ABRLD: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:⤷  Sign UpPatent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 27, 2012TE:ABRLD: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

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

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