Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202276

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STENDRA (AVANAFIL)
50MG
Marketing Status: Prescription

Active Ingredient: AVANAFIL
Proprietary Name: STENDRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202276
Product Number: 001
Approval Date: Apr 27, 2012
Applicant Holder Full Name: METUCHEN PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

STENDRA (AVANAFIL)
100MG
Marketing Status: Prescription

Active Ingredient: AVANAFIL
Proprietary Name: STENDRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202276
Product Number: 002
Approval Date: Apr 27, 2012
Applicant Holder Full Name: METUCHEN PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

STENDRA (AVANAFIL)
200MG
Marketing Status: Prescription

Active Ingredient: AVANAFIL
Proprietary Name: STENDRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202276
Product Number: 003
Approval Date: Apr 27, 2012
Applicant Holder Full Name: METUCHEN PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information