Details for New Drug Application (NDA): 214031
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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 214031
Tradename: | VARDENAFIL HYDROCHLORIDE |
Applicant: | Alembic |
Ingredient: | vardenafil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214031
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 214031
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 214031 | ANDA | Alembic Pharmaceuticals Limited | 46708-236 | 46708-236-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-236-30) |
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 214031 | ANDA | Alembic Pharmaceuticals Limited | 46708-236 | 46708-236-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-236-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Aug 4, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Aug 4, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Aug 4, 2020 | TE: | AB | RLD: | No |
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