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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021400

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LEVITRA (VARDENAFIL HYDROCHLORIDE)
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: LEVITRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021400
Product Number: 003
Approval Date: Aug 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LEVITRA (VARDENAFIL HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: LEVITRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021400
Product Number: 001
Approval Date: Aug 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LEVITRA (VARDENAFIL HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: LEVITRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021400
Product Number: 002
Approval Date: Aug 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LEVITRA (VARDENAFIL HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: VARDENAFIL HYDROCHLORIDE
Proprietary Name: LEVITRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021400
Product Number: 004
Approval Date: Aug 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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