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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 020487


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NDA 020487 describes VALTREX, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the VALTREX profile page.

The generic ingredient in VALTREX is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 020487
Tradename:VALTREX
Applicant:Glaxosmithkline
Ingredient:valacyclovir hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020487
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 020487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALTREX valacyclovir hydrochloride TABLET;ORAL 020487 NDA GlaxoSmithKline LLC 0173-0565 0173-0565-04 30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)
VALTREX valacyclovir hydrochloride TABLET;ORAL 020487 NDA GlaxoSmithKline LLC 0173-0565 0173-0565-10 90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)
Paragraph IV (Patent) Challenges for 020487
Tradename Dosage Ingredient NDA Submissiondate
VALTREX TABLET;ORAL valacyclovir hydrochloride 020487

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jun 23, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:Jun 23, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020487

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995   Start Trial   Start Trial
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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