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FDA Orange Book · active-ingredient family

Montelukast sodium

Montelukast sodium is approved as 3 brand and 49 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SINGULAIR · NDA 021409

3

Brand (NDA)

49

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · granule, tablet, tablet, chewable

ProductApplicantApplicationTEApproved
SINGULAIRRLDORGANONNDA 021409—Jul 26, 2002
SINGULAIRRLD×2ORGANONNDA 020830ABMar 03, 2000
SINGULAIRRLDORGANONNDA 020829ABFeb 20, 1998

Generic (ANDA) products (49)

ProductApplicantApplicationTEApproved
MONTELUKAST SODIUMBRECKENRIDGEANDA 205319—Oct 30, 2020
MONTELUKAST SODIUM×2AMNEAL PHARMSANDA 205107—Sep 04, 2020
MONTELUKAST SODIUMAUROBINDO PHARMA LTDANDA 213471ABFeb 18, 2020
MONTELUKAST SODIUM×2CHARTWELL MOLECULARANDA 207464ABDec 06, 2018
MONTELUKAST SODIUMTORRENTANDA 210431ABJul 31, 2018
MONTELUKAST SODIUM×2UNICHEMANDA 208621ABJul 02, 2018
MONTELUKAST SODIUML PERRIGO COANDA 206112—Apr 26, 2017
MONTELUKAST SODIUMRISINGANDA 209012ABApr 24, 2017
MONTELUKAST SODIUM×2RISINGANDA 209011ABApr 18, 2017
MONTELUKAST SODIUMCIPLAANDA 207463ABOct 28, 2016
MONTELUKAST SODIUMANBISON LABANDA 205683ABJan 12, 2016
MONTELUKAST SODIUM×2ANBISON LABANDA 205695ABNov 05, 2015
MONTELUKAST SODIUMUNICHEMANDA 204290ABOct 08, 2015
MONTELUKAST SODIUMAMNEAL PHARMSANDA 204604ABSep 04, 2015
MONTELUKAST SODIUMAJANTA PHARMA LTDANDA 203438ABJul 31, 2015
MONTELUKAST SODIUM×2AJANTA PHARMA LTDANDA 203328—Jul 31, 2015
MONTELUKAST SODIUMAJANTA PHARMA LTDANDA 203432—Jul 31, 2015
MONTELUKAST SODIUM×2HETERO LABS LTD VANDA 204093ABMay 22, 2015
MONTELUKAST SODIUM×2MACLEODS PHARMS LTDANDA 203582ABMar 12, 2015
MONTELUKAST SODIUM×2JUBILANT GENERICSANDA 203795—Feb 27, 2015
MONTELUKAST SODIUM×2PHARMOBEDIENTANDA 203037ABOct 30, 2014
MONTELUKAST SODIUMPHARMOBEDIENTANDA 202859ABOct 30, 2014
MONTELUKAST SODIUMMACLEODS PHARMS LTDANDA 203366ABSep 11, 2014
MONTELUKAST SODIUMHETERO LABS LTD VANDA 202843ABSep 10, 2014
MONTELUKAST SODIUMPHARMOBEDIENTANDA 202776—Dec 18, 2012
MONTELUKAST SODIUMACCORD HLTHCAREANDA 202717ABSep 21, 2012
MONTELUKAST SODIUMDR REDDYS LABS LTDANDA 202906ABSep 17, 2012
MONTELUKAST SODIUM×2SENORES PHARMSANDA 201581ABAug 06, 2012
MONTELUKAST SODIUMDR REDDYS LABS LTDANDA 201582ABAug 06, 2012
MONTELUKAST SODIUMTEVA PHARMSANDA 090955—Aug 03, 2012
MONTELUKAST SODIUM×2AIPING PHARM INCANDA 091414—Aug 03, 2012
MONTELUKAST SODIUM×2APOTEX INCANDA 201508—Aug 03, 2012
MONTELUKAST SODIUM×2AUROBINDO PHARMA LTDANDA 202096ABAug 03, 2012
MONTELUKAST SODIUM×2HIKMAANDA 091128—Aug 03, 2012
MONTELUKAST SODIUM×2LANNETT CO INCANDA 200405ABAug 03, 2012
MONTELUKAST SODIUM×2NATCO PHARMAANDA 079142—Aug 03, 2012
MONTELUKAST SODIUM×2PHARMACOANDA 091588—Aug 03, 2012
MONTELUKAST SODIUM×2TEVA PHARMSANDA 078723ABAug 03, 2012
MONTELUKAST SODIUM×2TORRENT PHARMS LTDANDA 090984ABAug 03, 2012
MONTELUKAST SODIUMAPOTEX CORPANDA 201294—Aug 03, 2012
MONTELUKAST SODIUMAUROBINDO PHARMA LTDANDA 202468ABAug 03, 2012
MONTELUKAST SODIUMCHARTWELL MOLECULARANDA 201522ABAug 03, 2012
MONTELUKAST SODIUMGLENMARK PHARMS LTDANDA 090926ABAug 03, 2012
MONTELUKAST SODIUMHIKMAANDA 090655—Aug 03, 2012
MONTELUKAST SODIUMPHARMOBEDIENTANDA 079103—Aug 03, 2012
MONTELUKAST SODIUMSANDOZ INCANDA 200889ABAug 03, 2012
MONTELUKAST SODIUMSTRIDES PHARMA INTLANDA 091576—Aug 03, 2012
MONTELUKAST SODIUMTEVA PHARMSANDA 078605ABAug 03, 2012
MONTELUKAST SODIUMTORRENT PHARMS LTDANDA 201515ABAug 03, 2012

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Montelukast sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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