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Details for New Drug Application (NDA): 200790

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NDA 200790 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: 200790

Tradename:
VALGANCICLOVIR HYDROCHLORIDE
Applicant:
Endo Pharms Inc
Ingredient:
valganciclovir hydrochloride
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 200790

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 200790

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL 200790 ANDA Qualitest Pharmaceuticals 0603-6330 0603-6330-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6330-20)
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL 200790 ANDA AvKARE, Inc. 42291-875 42291-875-60 60 TABLET, FILM COATED in 1 BOTTLE (42291-875-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Nov 4, 2014TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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