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Details for New Drug Application (NDA): 204750

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NDA 204750 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd V, and Endo Pharms Inc, and is included in five NDAs. It is available from eight suppliers. Additional details are available on the VALGANCICLOVIR HYDROCHLORIDE profile page.

The generic ingredient in VALGANCICLOVIR HYDROCHLORIDE is valganciclovir hydrochloride. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for NDA: 204750

Aurobindo Pharma Ltd
valganciclovir hydrochloride
Therapeutic Class:Antivirals

Pharmacology for NDA: 204750

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 204750

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
valganciclovir hydrochloride
TABLET;ORAL 204750 ANDA Aurobindo Pharma Limited 65862-753 65862-753-01 100 TABLET in 1 BOTTLE (65862-753-01)
valganciclovir hydrochloride
TABLET;ORAL 204750 ANDA Aurobindo Pharma Limited 65862-753 65862-753-05 500 TABLET in 1 BOTTLE (65862-753-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Mar 31, 2016TE:ABRLD:No

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