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Details for New Drug Application (NDA): 022145

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NDA 022145 describes ISENTRESS, which is a drug marketed by Merck Sharp Dohme and is included in three NDAs. It is available from eight suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ISENTRESS profile page.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Summary for NDA: 022145

Merck Sharp Dohme
raltegravir potassium
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022145

Mechanism of ActionHIV Integrase Inhibitors

Suppliers and Packaging for NDA: 022145

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
raltegravir potassium
TABLET;ORAL 022145 NDA A-S Medication Solutions 50090-1085 50090-1085-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0)

Summary for product number 001

Active Rx/OTC/Discontinued:YesDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Oct 12, 2007TE:RLD:Yes
Patent:7,169,780Patent Expiration:Oct 3, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:7,435,734Patent Expiration:Oct 21, 2022Product Flag?Substance Flag?Delist Request?
Patent:7,217,713Patent Expiration:Oct 21, 2022Product Flag?Substance Flag?Delist Request?

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