DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205166
NDA 205166 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Endo Pharms Inc, and Hetero Labs Ltd V, and is included in six NDAs. It is available from twelve suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.
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.
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 | ||||
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