raltegravir Chewable Tablet

Brand(s)
Isentress
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-02-20)
Oldest Current Product
2011-12-21
License(s)
NDA
RxNORM
CHEWABLE TABLET\RALTEGRAVIR
FDAOB
ORAL\TABLET, CHEWABLE\RALTEGRAVIR POTASSIUM
SPL Active
ORAL\TABLET, CHEWABLE\RALTEGRAVIR POTASSIUM
SPL Moiety
ORAL\TABLET, CHEWABLE\RALTEGRAVIR

product(s) by strength(s)

raltegravir 100 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060477IsentressNDAMerck Sharp & Dohme Corp.2011-12-21RALTEGRAVIR POTASSIUMORALTABLET, CHEWABLENDA20304589a5ec53-d956-4329-8004-0f40f51c88a3

raltegravir 25 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060473IsentressNDAMerck Sharp & Dohme Corp.2011-12-21RALTEGRAVIR POTASSIUMORALTABLET, CHEWABLENDA20304589a5ec53-d956-4329-8004-0f40f51c88a3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203045ISENTRESSMERCK SHARP AND DOHME CORP2011-12-21p7435734, TREATMENT OF HIV INFECTION
p7754731, TREATMENT OF HIV INFECTION, SUBSTANCE
p7169780, SUBSTANCE
p7217713, TREATMENT OF HIV INFECTION
NEW DOSAGE FORM [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]
NDA203045_001, NDA203045_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203045_001RXRALTEGRAVIR POTASSIUM (EQ 25MG BASE)ORALTABLET, CHEWABLEFalse2011-12-21ISENTRESS
2NDA203045_002RXRALTEGRAVIR POTASSIUM (EQ 100MG BASE)ORALTABLET, CHEWABLETrue2011-12-21ISENTRESS

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
189a5ec53-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, PACK2015-02-2049000060473, 000060477, 000060227, 000063603raltegravir Oral Suspension
raltegravir Oral Tablet

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