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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091347

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VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 2.5MG BASE
Marketing Status: Prescription
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: VARDENAFIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091347
Product Number: 001
Approval Date: May 3, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: VARDENAFIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091347
Product Number: 002
Approval Date: May 3, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: VARDENAFIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091347
Product Number: 003
Approval Date: May 3, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: VARDENAFIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091347
Product Number: 004
Approval Date: May 3, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
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