raltegravir Oral Tablet

Brand(s)
Isentress
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-02-20)
Oldest Current Product
2007-10-12
License(s)
NDA
RxNORM
ORAL TABLET\RALTEGRAVIR
FDAOB
ORAL\TABLET\RALTEGRAVIR POTASSIUM
SPL Active
ORAL\TABLET, FILM COATED\RALTEGRAVIR POTASSIUM
SPL Moiety
ORAL\TABLET, FILM COATED\RALTEGRAVIR

product(s) by strength(s)

raltegravir 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060227IsentressNDAMerck Sharp & Dohme Corp.2007-10-12RALTEGRAVIR POTASSIUMORALTABLET, FILM COATEDNDA02214589a5ec53-d956-4329-8004-0f40f51c88a3

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490430IsentressNDARemedyrepack Inc.2013-04-10RALTEGRAVIR POTASSIUMORALTABLET, FILM COATED000060227NDA02214586cf38ed-102b-4171-bc44-01dfc1c236c2, e463b253-ad05-4e5c-8a3b-595d55c56ed7
2538080650IsentressNDAState Of Florida Doh Central Pharmacy2009-07-01RALTEGRAVIR POTASSIUMORALTABLET, FILM COATED000060227NDA022145cbd3e1af-81f3-44f6-8e45-652deab7a508
3548680117IsentressNDAPhysicians Total Care, Inc.2008-04-23RALTEGRAVIR POTASSIUMORALTABLET, FILM COATED000060227NDA022145c2ee4728-3388-4ad7-8512-e632b69557d4
4663360214IsentressNDADispensing Solutions, Inc.2007-10-12RALTEGRAVIR POTASSIUMORALTABLET, FILM COATED000060227NDA022145b05735be-d278-4c31-bfb5-ebf74ce42b89

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022145ISENTRESSMERCK SHARP AND DOHME CORP2007-10-12p7435734, TREATMENT OF HIV INFECTION/ INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
p7754731, TREATMENT OF HIV INFECTION, SUBSTANCE
p7169780, SUBSTANCE
p7217713, TREATMENT OF HIV INFECTION
NEW PATIENT POPULATION [2014-12-21]
CHANGES IN SECTION 14 OF THE PACKAGE INSERT TO INCLUDE DATA FROM THE SWITCHMRK STUDIES (SWITCH OF SUPPRESSED SUBJECTS FROM LOPINAVIR/RITONAVIR TO RALTEGRAVIR) [2015-03-28]
NDA022145_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022145_001RXRALTEGRAVIR POTASSIUM (EQ 400MG BASE)ORALTABLETTrue2007-10-12ISENTRESS

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7169780 (view patent)2023-10-03NDA022145, NDA203045, NDA205786, NDA206510raltegravir Chewable Tablet
raltegravir Oral Suspension
2p7217713 (view patent)2022-10-21NDA022145, NDA203045, NDA205786, NDA206510raltegravir Chewable Tablet
raltegravir Oral Suspension
3p7435734 (view patent)2022-10-21NDA022145, NDA203045, NDA205786, NDA206510raltegravir Chewable Tablet
raltegravir Oral Suspension
4p7754731 (view patent)2029-03-11NDA022145, NDA203045, NDA205786, NDA206510raltegravir Chewable Tablet
raltegravir Oral Suspension

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
186cf38ed-102b-4171-bc44-01dfc1c236c2 (view SPL)These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) Film-Coated Tablets, for oral use ISENTRESS (raltegravir) Chewable Tablets, for oral use Initial U.S. Approval: 2007prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-101493490430
289a5ec53-d956-4329-8004-0f40f51c88a3 (view SPL)These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) film-coated tablets, for oral use ISENTRESS (raltegravir) chewable tablets, for oral use ISENTRESS (raltegravir) for oral suspension Initial U.S. Approval: 2007prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-02-2049000060227, 000060473, 000060477, 000063603raltegravir Chewable Tablet
raltegravir Oral Suspension
3b05735be-d278-4c31-bfb5-ebf74ce42b89 (view SPL)These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) Film-Coated Tablets, for oral use ISENTRESS (raltegravir) Chewable Tablets, for oral use Initial U.S. Approval: 2007prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-06-252663360214
4c2ee4728-3388-4ad7-8512-e632b69557d4 (view SPL)These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) Film-Coated Tablets, for oral use ISENTRESS (raltegravir) Chewable Tablets, for oral use Initial U.S. Approval: 2007prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-072548680117
5cbd3e1af-81f3-44f6-8e45-652deab7a508 (view SPL)These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) TabletsInitial U.S. Approval: 2007prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-08-113538080650
6e463b253-ad05-4e5c-8a3b-595d55c56ed7 (view SPL)These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS (raltegravir) Film-Coated Tablets, for oral use ISENTRESS (raltegravir) Chewable Tablets, for oral use Initial U.S. Approval: 2007prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-101493490430

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII