U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021400

Expand all

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EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: 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EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: 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 **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 20MG 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: 004
Approval Date: Aug 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top