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Generated: November 16, 2018

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Details for New Drug Application (NDA): 022145

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NDA 022145 describes ISENTRESS HD, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from nine suppliers. There are five patents protecting this drug. Additional details are available on the ISENTRESS HD profile page.

The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 022145
Tradename:ISENTRESS HD
Applicant:Merck Sharp Dohme
Ingredient:raltegravir potassium
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 022145
Mechanism of ActionHIV Integrase Inhibitors
Medical Subject Heading (MeSH) Categories for 022145
Suppliers and Packaging for NDA: 022145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISENTRESS raltegravir potassium TABLET;ORAL 022145 NDA Merck Sharp & Dohme Corp. 0006-0227 0006-0227-61 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61)
ISENTRESS HD raltegravir potassium TABLET;ORAL 022145 NDA Merck Sharp & Dohme Corp. 0006-0227 0006-0227-61 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Oct 12, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:May 26, 2020
Regulatory Exclusivity Use:ADDITION OF 1200 MG ONCE DAILY DOSING FOR TREATMENT-NAIVE PATIENTS OR PATIENTS WHO ARE VIROLOGICALLY SUPPRESSED ON AN INITIAL REGIMEN OF RALTEGRAVIR FILM-COATED TABLETS 400 MG TWICE DAILY
Regulatory Exclusivity Expiration:Nov 22, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:May 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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