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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204750


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NDA 204750 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-one 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-three suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 204750
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:valganciclovir hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204750
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 valganciclovir hydrochloride TABLET;ORAL 204750 ANDA Mckesson Corporation DBA SKY Packaginng 63739-357 63739-357-33 3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-357-33) / 10 TABLET in 1 BLISTER PACK
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride TABLET;ORAL 204750 ANDA Aurobindo Pharma Limited 65862-753 65862-753-01 100 TABLET in 1 BOTTLE (65862-753-01)

Profile for product number 001

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

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