Details for New Drug Application (NDA): 208324
✉ Email this page to a colleague
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 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.
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 208324
| Tradename: | VARDENAFIL HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | vardenafil hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208324
| Mechanism of Action | Phosphodiesterase 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: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 16, 2018 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
