Details for New Drug Application (NDA): 204632
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NDA 204632 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 twelve 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
Summary for 204632
| Tradename: | VARDENAFIL HYDROCHLORIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | vardenafil hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204632
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 204632
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 204632 | ANDA | Macleods Pharmaceuticals Limited | 33342-151 | 33342-151-07 | 30 TABLET in 1 BOTTLE (33342-151-07) |
| VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 204632 | ANDA | Macleods Pharmaceuticals Limited | 33342-151 | 33342-151-11 | 100 TABLET in 1 BOTTLE (33342-151-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Oct 22, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Oct 22, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Oct 22, 2019 | TE: | AB | RLD: | No | ||||
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