Details for New Drug Application (NDA): 205988
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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 205988
Tradename: | VARDENAFIL HYDROCHLORIDE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | vardenafil hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205988
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 205988
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | vardenafil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 205988 | ANDA | Macleods Pharmaceuticals Limited | 33342-203 | 33342-203-37 | 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 10, 2020 | TE: | AB | RLD: | No |
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