Product Details for ANDA 208960
VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)
EQ 2.5MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Prescription
EQ 20MG BASE
Marketing Status: Prescription
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: A208960
Product Number: 001
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
VARDENAFIL HYDROCHLORIDE (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: A208960
Product Number: 001
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A208960
Product Number: 002
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
VARDENAFIL HYDROCHLORIDE (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: A208960
Product Number: 002
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A208960
Product Number: 003
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
VARDENAFIL HYDROCHLORIDE (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: A208960
Product Number: 003
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: Yes
TE Code: AB
Application Number: A208960
Product Number: 004
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: VARDENAFIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A208960
Product Number: 004
Approval Date: Oct 31, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information