DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205166
The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 205166
Tradename: | VALGANCICLOVIR HYDROCHLORIDE |
Applicant: | Hetero Labs Ltd V |
Ingredient: | valganciclovir hydrochloride |
Patents: | 0 |
Therapeutic Class: | Antivirals |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205166
Ingredient-type | Nucleoside Analog |
Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 205166
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 205166 | ANDA | Camber Pharmaceuticals, Inc. | 31722-832 | N | 31722-832-31 |
VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 205166 | ANDA | Camber Pharmaceuticals, Inc. | 31722-832 | N | 31722-832-32 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 450MG BASE | ||||
Approval Date: | Mar 18, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription