Details for New Drug Application (NDA): 205166
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NDA 205166 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Mylan, and Strides Pharma, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.
The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Twenty-four 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 seventeen drug master file entries for this compound. Twenty-four 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205166
| 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 | Major Pharmaceuticals | 0904-6796 | 0904-6796-04 | 30 BLISTER PACK in 1 CARTON (0904-6796-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| VALGANCICLOVIR HYDROCHLORIDE | valganciclovir hydrochloride | TABLET;ORAL | 205166 | ANDA | Major Pharmaceuticals | 0904-6796 | 0904-6796-10 | 20 BLISTER PACK in 1 CARTON (0904-6796-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
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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