Details for New Drug Application (NDA): 209057
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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 209057
Tradename: | VARDENAFIL HYDROCHLORIDE |
Applicant: | Crossmedika Sa |
Ingredient: | vardenafil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 209057
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 209057
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 209057 | ANDA | Lannett Company, Inc. | 0527-2800 | 0527-2800-32 | 30 TABLET in 1 BOTTLE (0527-2800-32) |
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 209057 | ANDA | Lannett Company, Inc. | 0527-2801 | 0527-2801-32 | 30 TABLET in 1 BOTTLE (0527-2801-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Oct 31, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Oct 31, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Oct 31, 2018 | TE: | AB | RLD: | No |
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