Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210738

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VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Discontinued

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: 
Application Number: A210738
Product Number: 001
Approval Date: Oct 31, 2018
Applicant Holder Full Name: JEROME STEVENS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Discontinued

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: 
Application Number: A210738
Product Number: 002
Approval Date: Oct 31, 2018
Applicant Holder Full Name: JEROME STEVENS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Discontinued

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: 
Application Number: A210738
Product Number: 003
Approval Date: Oct 31, 2018
Applicant Holder Full Name: JEROME STEVENS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information