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Last Updated: December 1, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212890


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NDA 212890 describes VALGANCICLOVIR HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Granules, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Dr Reddys Labs Ltd, Endo Pharms Inc, Hetero Labs Ltd V, and Mylan, and is included in eleven NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 212890
Tradename:VALGANCICLOVIR HYDROCHLORIDE
Applicant:Ajanta Pharma Ltd
Ingredient:valganciclovir hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212890
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 212890
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE valganciclovir hydrochloride FOR SOLUTION;ORAL 212890 ANDA Ajanta Pharma USA Inc. 27241-159 27241-159-19 1 POUCH in 1 CARTON (27241-159-19) > 1 BOTTLE in 1 POUCH > 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Jan 13, 2020TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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