Details for New Drug Application (NDA): 202276
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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: | ⤷ Sign Up | 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
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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