Details for New Drug Application (NDA): 208960
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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 208960
Tradename: | VARDENAFIL HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | vardenafil hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208960
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 208960
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 208960 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1068 | 70710-1068-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1068-1) |
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET;ORAL | 208960 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1068 | 70710-1068-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1068-3) |
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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