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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208324


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NDA 208324 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 thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
Summary for 208324
Tradename:VARDENAFIL HYDROCHLORIDE
Applicant:Alembic
Ingredient:vardenafil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208324
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Suppliers and Packaging for NDA: 208324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 208324 ANDA Alembic Pharmaceuticals Limited 46708-235 46708-235-04 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)
VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 208324 ANDA Alembic Pharmaceuticals Inc. 62332-235 62332-235-04 4 BLISTER PACK in 1 CARTON (62332-235-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Nov 16, 2018TE:ABRLD:No

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