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Last Updated: October 7, 2024

Details for New Drug Application (NDA): 208960


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NDA 208960 describes VARDENAFIL HYDROCHLORIDE, which is a drug marketed by Alembic, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the VARDENAFIL HYDROCHLORIDE profile page.

The generic ingredient in VARDENAFIL HYDROCHLORIDE is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
Summary for 208960
Tradename:VARDENAFIL HYDROCHLORIDE
Applicant:Zydus Pharms
Ingredient:vardenafil hydrochloride
Patents:0
Pharmacology for NDA: 208960
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Suppliers and Packaging for NDA: 208960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960 ANDA Zydus Pharmaceuticals USA Inc. 70710-1068 70710-1068-1 100 TABLET, FILM COATED in 1 BOTTLE (70710-1068-1)
VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960 ANDA Zydus Pharmaceuticals USA Inc. 70710-1068 70710-1068-3 30 TABLET, FILM COATED in 1 BOTTLE (70710-1068-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Oct 31, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Oct 31, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 31, 2018TE:ABRLD:No

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