montelukast Chewable Tablet

Brand(s)
Singulair
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-03-11)
Oldest Current Product
1998-02-20
License(s)
NDA, ANDA
RxNORM
CHEWABLE TABLET\MONTELUKAST
FDAOB
ORAL\TABLET, CHEWABLE\MONTELUKAST SODIUM
SPL Active
ORAL\TABLET, CHEWABLE\MONTELUKAST
ORAL\TABLET, CHEWABLE\MONTELUKAST SODIUM
SPL Moiety
ORAL\TABLET, CHEWABLE\MONTELUKAST

product(s) by strength(s)

montelukast 4 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000061711SingulairNDAMerck Sharp & Dohme Corp.1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLENDA0208308c166755-7711-4df9-d689-8836a1a70885

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540288ANDARoxane Laboratories, Inc2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA091128d606a983-3146-4f50-a9d5-634cb4aef580
2000937424ANDATeva Pharmaceuticals Usa Inc2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA0787234eabe2b1-7f4d-4720-bf70-191e6df67c79
3003785204ANDAMylan Pharmaceuticals Inc.2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA0791429794b747-3a45-48eb-9c3e-bc5b015f6591
4006034653ANDAQualitest Pharmaceuticals2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA091588a5620aa9-3028-48e1-a9d2-0860a8fe7e1d
5007815554ANDASandoz Inc2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA0914146d69e73a-76cb-4ece-9cf9-e9adb4f523b4
6136680079ANDATorrent Pharmaceuticals Limited2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA090984da038cf6-cfad-43a4-ab8e-d81d028d6087
7272410016ANDAAjanta Pharma Limited2015-11-10MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA20332867070e4e-f755-46b3-b900-fcc1993a0546
8317220727ANDACamber Pharmaceuticals, Inc.2015-05-27MONTELUKASTORALTABLET, CHEWABLEANDA20409323964723-2df8-4d0a-a53d-8538469672f1
9333420110ANDAMacleods Pharmaceuticals Limited2014-04-01MONTELUKASTORALTABLET, CHEWABLEANDA203582ce512844-5220-4661-809f-56d088699c9c
10551110593ANDADr. Reddy'S Laboratories Ltd2012-08-06MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA2015813d4451a9-d73d-b9de-68ec-853bfeff6e4b
11597460358ANDAJubilant Cadista Pharmaceuticals, Inc.2015-02-28MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA20379576d4a034-0082-1d94-5f92-6b071da7cadd
12605053573ANDAApotex Corp2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA201508b2de3aab-8346-047c-9e34-de9fec43fb39
13621750204ANDAKremers Urban Pharmaceuticals Inc.2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA200405c43d1edb-c162-4317-9a89-d84e4eff5512
14658620567ANDAAurobindo Pharma Limited2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA202096ba42b0a9-83f1-4283-a853-f99cdd0761b9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910622ANDAAvkare, Inc.2013-01-02MONTELUKAST SODIUMORALTABLET, CHEWABLE621750204ANDA200405ed2caffa-a75c-1c27-ae30-2d8280eaea7d
2430630381ANDAPd-Rx Pharmaceuticals, Inc.2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLE136680079ANDA090984c69ab399-8ea6-4002-9271-b6a57c862b14
3499990952SingulairNDALake Erie Medical Dba Quality Care Products Llc2012-03-21MONTELUKAST SODIUMORALTABLET, CHEWABLE000060711NDA02083034eee405-05c1-449a-a06f-ca676056c665
4502680573ANDAAvpak2014-11-11MONTELUKAST SODIUMORALTABLET, CHEWABLE621750204ANDA2004052f90a573-27fd-cc16-f3d1-8c4d630224a0
5545695167SingulairNDAA-S Medication Solutions Llc1999-04-23MONTELUKAST SODIUMORALTABLET, CHEWABLE000060711NDA020830a99f55de-39d1-483a-ba88-dbda5613c6a7
6548684630SingulairNDAPhysicians Total Care, Inc.2002-05-30MONTELUKAST SODIUMORALTABLET, CHEWABLE000060711NDA020830e8d9021d-73aa-4c96-8b8a-e90069e78555
7548686363ANDAPhysicians Total Care, Inc.2012-08-09MONTELUKAST SODIUMORALTABLET, CHEWABLE000937424ANDA07872309692f56-468c-4884-ae95-d2fb9d984e4c
8552890989SingulairNDAPd-Rx Pharmaceuticals, Inc.1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLE000060711NDA0208301525056d-c2c2-4956-9ed5-2d925bff459b
9631870550ANDAProficient Rx Lp2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLE136680079ANDA09098407d5fbea-b183-41c9-a20f-30da1f44ab1b
10636292979SingulairNDABryant Ranch Prepack1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLE000060711NDA020830485540c7-d19b-4d46-b086-d5f659a7bb67
11636294855ANDABryant Ranch Prepack2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLE605053573ANDA2015082b0b00f0-df0d-466d-a7b5-4749862bbdc2
12680840638ANDAAmerican Health Packaging2013-05-22MONTELUKAST SODIUMORALTABLET, CHEWABLE605053573ANDA2015087caa5173-dacc-4ab4-aa6f-3324001cddc2
13681514338ANDACarilion Materials Management2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLE000937424ANDA0787238bc91794-7577-486a-916b-92edadf17cd7
14687889439ANDAPreferred Pharmaceuticals, Inc.2014-05-05MONTELUKAST SODIUMORALTABLET, CHEWABLE006034653ANDA091588030edd89-4d48-4741-bebc-e22ec053613a

montelukast 5 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000069275SingulairNDAMerck Sharp & Dohme Corp.1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLENDA0208308c166755-7711-4df9-d689-8836a1a70885

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540289ANDARoxane Laboratories, Inc2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA091128d606a983-3146-4f50-a9d5-634cb4aef580
2000937425ANDATeva Pharmaceuticals Usa Inc2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA0787234eabe2b1-7f4d-4720-bf70-191e6df67c79
3003785205ANDAMylan Pharmaceuticals Inc.2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA0791429794b747-3a45-48eb-9c3e-bc5b015f6591
4006034654ANDAQualitest Pharmaceuticals2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA091588a5620aa9-3028-48e1-a9d2-0860a8fe7e1d
5007815555ANDASandoz Inc2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA0914146d69e73a-76cb-4ece-9cf9-e9adb4f523b4
6272410017ANDAAjanta Pharma Limited2015-11-10MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA20332867070e4e-f755-46b3-b900-fcc1993a0546
7317220728ANDACamber Pharmaceuticals, Inc.2015-05-27MONTELUKASTORALTABLET, CHEWABLEANDA20409323964723-2df8-4d0a-a53d-8538469672f1
8333420111ANDAMacleods Pharmaceuticals Limited2013-12-27MONTELUKASTORALTABLET, CHEWABLEANDA203582ce512844-5220-4661-809f-56d088699c9c
9551110594ANDADr. Reddy'S Laboratories Ltd2012-08-06MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA2015813d4451a9-d73d-b9de-68ec-853bfeff6e4b
10597460359ANDAJubilant Cadista Pharmaceuticals, Inc.2015-02-28MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA20379576d4a034-0082-1d94-5f92-6b071da7cadd
11605053574ANDAApotex Corp2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA201508b2de3aab-8346-047c-9e34-de9fec43fb39
12621750205ANDAKremers Urban Pharmaceuticals Inc.2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA200405c43d1edb-c162-4317-9a89-d84e4eff5512
13658620568ANDAAurobindo Pharma Limited2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLEANDA202096ba42b0a9-83f1-4283-a853-f99cdd0761b9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950565SingulairNDARebel Distributors Corp1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLE000060275NDA02083078eea56d-15a6-4ceb-b755-d1a3e9707f32
2422910623ANDAAvkare, Inc.2013-01-02MONTELUKAST SODIUMORALTABLET, CHEWABLE621750205ANDA200405ed2caffa-a75c-1c27-ae30-2d8280eaea7d
3499990884SingulairNDALake Erie Medical Dba Quality Care Products Llc2012-03-21MONTELUKAST SODIUMORALTABLET, CHEWABLE000060275NDA02083034eee405-05c1-449a-a06f-ca676056c665
4502680574ANDAAvpak2014-11-12MONTELUKAST SODIUMORALTABLET, CHEWABLE621750205ANDA2004052f90a573-27fd-cc16-f3d1-8c4d630224a0
5545694736SingulairNDAA-S Medication Solutions Llc2000-11-10MONTELUKAST SODIUMORALTABLET, CHEWABLE000060275NDA020830a99f55de-39d1-483a-ba88-dbda5613c6a7
6548684847SingulairNDAPhysicians Total Care, Inc.2003-07-03MONTELUKAST SODIUMORALTABLET, CHEWABLE000060275NDA020830e8d9021d-73aa-4c96-8b8a-e90069e78555
7548686362ANDAPhysicians Total Care, Inc.2012-08-09MONTELUKAST SODIUMORALTABLET, CHEWABLE000937425ANDA07872309692f56-468c-4884-ae95-d2fb9d984e4c
8551545029SingulairNDACardinal Health1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLE000060275NDA020830d7434c6c-5a26-46e0-bade-0c54d71112fc
9636293701SingulairNDABryant Ranch Prepack1998-02-20MONTELUKAST SODIUMORALTABLET, CHEWABLE000060275NDA020830bb2ed030-851f-495c-adb6-8708c4b64f1b
10636294978ANDABryant Ranch Prepack2012-08-03MONTELUKAST SODIUMORALTABLET, CHEWABLE658620568ANDA2020966e0393b3-38c8-49e6-a0ff-875499974a51
11680840619ANDAAmerican Health Packaging2012-07-02MONTELUKAST SODIUMORALTABLET, CHEWABLE605053574ANDA2015087caa5173-dacc-4ab4-aa6f-3324001cddc2
12680840864ANDAAmerican Health Packaging2015-02-15MONTELUKAST SODIUMORALTABLET, CHEWABLE551110594ANDA201581fb1b2e4e-a840-447b-b943-ad0b6acc32b5
13682583032SingulairNDADispensing Solutions, Inc.2009-10-08MONTELUKAST SODIUMORALTABLET, CHEWABLE00006027531NDA02083010cd5ca5-6f8b-417c-af11-a2054a2dde34

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1ANDA078723MONTELUKAST SODIUMTEVA PHARMACEUTICALS USA2012-08-03ANDA078723_001, ANDA078723_002
2ANDA079142MONTELUKAST SODIUMMYLAN PHARMACEUTICALS INC2012-08-03ANDA079142_001, ANDA079142_002
3ANDA090984MONTELUKAST SODIUMTORRENT PHARMACEUTICALS LTD2012-08-03ANDA090984_001, ANDA090984_002
4ANDA091128MONTELUKAST SODIUMROXANE LABORATORIES INC2012-08-03ANDA091128_001, ANDA091128_002
5ANDA091414MONTELUKAST SODIUMSANDOZ INC2012-08-03ANDA091414_001, ANDA091414_002
6ANDA091588MONTELUKAST SODIUMVINTAGE PHARMACEUTICALS LLC2012-08-03ANDA091588_001, ANDA091588_002
7ANDA200405MONTELUKAST SODIUMKREMERS URBAN PHARMACEUTICALS INC2012-08-03ANDA200405_001, ANDA200405_002
8ANDA201508MONTELUKAST SODIUMAPOTEX INC2012-08-03ANDA201508_001, ANDA201508_002
9ANDA201581MONTELUKAST SODIUMDR REDDYS LABORATORIES LTD2012-08-06ANDA201581_001, ANDA201581_002
10ANDA202096MONTELUKAST SODIUMAUROBINDO PHARMA LTD2012-08-03ANDA202096_001, ANDA202096_002
11ANDA203037MONTELUKAST SODIUMUNIMARK REMEDIES LTD2014-10-30ANDA203037_001, ANDA203037_002
12ANDA203328MONTELUKAST SODIUMAJANTA PHARMA LTD2015-07-31ANDA203328_001, ANDA203328_002
13ANDA203582MONTELUKAST SODIUMMACLEODS PHARMACEUTICALS LTD2015-03-12ANDA203582_001, ANDA203582_002
14ANDA203795MONTELUKAST SODIUMJUBILANT GENERICS LTD2015-02-27ANDA203795_001, ANDA203795_002
15ANDA204093MONTELUKAST SODIUMHETERO LABS LTD UNIT V2015-05-22ANDA204093_001, ANDA204093_002
16ANDA205695MONTELUKAST SODIUMANBISON LABORATORY CO LTD2015-11-05ANDA205695_001, ANDA205695_002
17NDA020830SINGULAIRMERCK AND CO INC1998-02-20NEW PATIENT POPULATION [2015-03-26]NDA020830_001, NDA020830_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078723_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
2ANDA078723_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
3ANDA079142_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
4ANDA079142_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
5ANDA090984_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
6ANDA090984_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
7ANDA091128_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
8ANDA091128_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
9ANDA091414_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
10ANDA091414_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
11ANDA091588_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
12ANDA091588_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
13ANDA200405_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
14ANDA200405_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
15ANDA201508_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
16ANDA201508_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
17ANDA201581_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-06MONTELUKAST SODIUM
18ANDA201581_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-06MONTELUKAST SODIUM
19ANDA202096_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
20ANDA202096_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2012-08-03MONTELUKAST SODIUM
21ANDA203037_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2014-10-30MONTELUKAST SODIUM
22ANDA203037_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2014-10-30MONTELUKAST SODIUM
23ANDA203328_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2015-07-31MONTELUKAST SODIUM
24ANDA203328_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2015-07-31MONTELUKAST SODIUM
25ANDA203582_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2015-03-12MONTELUKAST SODIUM
26ANDA203582_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2015-03-12MONTELUKAST SODIUM
27ANDA203795_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2015-02-27MONTELUKAST SODIUM
28ANDA203795_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2015-02-27MONTELUKAST SODIUM
29ANDA204093_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2015-05-22MONTELUKAST SODIUM
30ANDA204093_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2015-05-22MONTELUKAST SODIUM
31ANDA205695_001RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2015-11-05MONTELUKAST SODIUM
32ANDA205695_002RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLEFalseAB2015-11-05MONTELUKAST SODIUM
33NDA020830_001RXMONTELUKAST SODIUM (EQ 5MG BASE)ORALTABLET, CHEWABLETrueAB1998-02-20SINGULAIR
34NDA020830_002RXMONTELUKAST SODIUM (EQ 4MG BASE)ORALTABLET, CHEWABLEFalseAB2000-03-03SINGULAIR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1030edd89-4d48-4741-bebc-e22ec053613a (view SPL)These highlights do not include all the information needed to use Montelukast sodiumsafely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-05-081687889439
207d5fbea-b183-41c9-a20f-30da1f44ab1b (view SPL)These highlights do not include all the information needed to use Montelukast Sodium safely and effectively. See full prescribing information for Montelukast Sodium. Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870550
309692f56-468c-4884-ae95-d2fb9d984e4c (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium.MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-142548686362, 548686363, 548686361montelukast Oral Tablet
410cd5ca5-6f8b-417c-af11-a2054a2dde34 (view SPL)SINGULAIR(MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULESprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2010-03-011682583032, 682583033montelukast Oral Tablet
51525056d-c2c2-4956-9ed5-2d925bff459b (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) Tablets, Chewable Tablets, and Oral GranulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-2826552890989
623964723-2df8-4d0a-a53d-8538469672f1 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use montelukast sodium chewable tablets safely and effectively. See full prescribing information for montelukast sodium chewable tablets.MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-05-271317220727, 317220728
72b0b00f0-df0d-466d-a7b5-4749862bbdc2 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. Montelukast Sodium Tablets and Montelukast Sodium Chewable TabletsInitial U.S. Approval:1998prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081001636294855
82f90a573-27fd-cc16-f3d1-8c4d630224a0 (view SPL)These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAvpak2014-10-022502680573, 502680574, 502680575montelukast Oral Tablet
934eee405-05c1-449a-a06f-ca676056c665 (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) Tablets, Chewable Tablets, and Oral GranulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-213686499990884, 499990952, 499990533montelukast Oral Tablet
103d4451a9-d73d-b9de-68ec-853bfeff6e4b (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST sodium tablets, for oral useMONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-06-0217551110593, 551110594, 551110725montelukast Oral Tablet
11485540c7-d19b-4d46-b086-d5f659a7bb67 (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) Tablets, Chewable Tablets, and Oral GranulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636292979
124eabe2b1-7f4d-4720-bf70-191e6df67c79 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium.MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-127000937424, 000937425, 000937426montelukast Oral Tablet
1367070e4e-f755-46b3-b900-fcc1993a0546 (view SPL)These highlights do not include all the information needed to use MONTELUKAST sodium tablets, chewable tablets and oral granules safely and effectively. See full prescribing information for MONTELUKAST sodium tablets, chewable tablets and oral granules. MONTELUKAST sodium tablets, chewable tablets and oral granulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionAjanta Pharma LimitedMANUFACTURE2015-11-059272410016, 272410017, 272410015, 272410018montelukast Oral Granules
montelukast Oral Tablet
146d69e73a-76cb-4ece-9cf9-e9adb4f523b4 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionSandoz Inc2015-08-257007815554, 007815555, 007815560montelukast Oral Tablet
156e0393b3-38c8-49e6-a0ff-875499974a51 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium chewable tablets. Montelukast Sodium Chewable TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-101001636294978
1676d4a034-0082-1d94-5f92-6b071da7cadd (view SPL)These highlights do not include all the information needed to use montelukast sodium chewable tablets safely and effectively. See full prescribing information for montelukast sodium chewable tablets. Montelukast Sodium Chewable Tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2015-02-281597460358, 597460359
1778eea56d-15a6-4ceb-b755-d1a3e9707f32 (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) tablets, chewable tablets, and oral granulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950565, 216950221montelukast Oral Tablet
187caa5173-dacc-4ab4-aa6f-3324001cddc2 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. Montelukast Sodium Tablets and Montelukast Sodium Chewable TabletsInitial U.S. Approval:1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-02-113680840619, 680840638, 680840620montelukast Oral Tablet
198bc91794-7577-486a-916b-92edadf17cd7 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-02-264681514338
208c166755-7711-4df9-d689-8836a1a70885 (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) Tablets, Chewable Tablets, and Oral GranulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2015-03-1148000061711, 000069275, 000063841, 000069117montelukast Oral Granules
montelukast Oral Tablet
219794b747-3a45-48eb-9c3e-bc5b015f6591 (view SPL)These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKSAT SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-11-189003785204, 003785205, 003785201, 003786040montelukast Oral Granules
montelukast Oral Tablet
22a5620aa9-3028-48e1-a9d2-0860a8fe7e1d (view SPL)These highlights do not include all the information needed to use Montelukast sodiumsafely and effectively. See full prescribing information for Montelukast sodium. MONTELUKAST sodium tablets and MONTELUKAST chewable tablets,for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionQualitest Pharmaceuticals2015-05-0820006034653, 006034654, 006034655montelukast Oral Tablet
23a99f55de-39d1-483a-ba88-dbda5613c6a7 (view SPL)SINGULAIR(MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULESprescriptionHuman PrescriptionA-S Medication Solutions Llc2009-09-0812545694736, 545695167, 545694605montelukast Oral Tablet
24b2de3aab-8346-047c-9e34-de9fec43fb39 (view SPL)These highlights do not include all the information needed to use MONTELUKAST sodium tablets safely and effectively. See full prescribing information for MONTELUKAST sodium tablets. MONTELUKAST sodium tablets and MONTELUKAST sodiumchewable tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-04-307605053573, 605053574, 605053562montelukast Oral Tablet
25ba42b0a9-83f1-4283-a853-f99cdd0761b9 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, MANUFACTURE2015-05-207658620567, 658620568, 658620574montelukast Oral Tablet
26bb2ed030-851f-495c-adb6-8708c4b64f1b (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) Tablets, Chewable Tablets, and Oral GranulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636293701
27c43d1edb-c162-4317-9a89-d84e4eff5512 (view SPL)These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.2015-06-0421621750204, 621750205, 621750210montelukast Oral Tablet
28c69ab399-8ea6-4002-9271-b6a57c862b14 (view SPL)These highlights do not include all the information needed to use Montelukast Sodium safely and effectively. See full prescribing information for Montelukast Sodium. Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-057430630381
29ce512844-5220-4661-809f-56d088699c9c (view SPL)These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE. MONTELUKAST Sodium Chewable Tablets For Oral Use Initial U.S. Approval 1998prescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-03-232333420110, 333420111
30d606a983-3146-4f50-a9d5-634cb4aef580 (view SPL)These highlights do not include all the information needed to use Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets safely and effectively. See full prescribing information for Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets. Montelukast Sodium TabletsMontelukast Sodium Chewable TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-01-012000540288, 000540289, 000540259montelukast Oral Tablet
31d7434c6c-5a26-46e0-bade-0c54d71112fc (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) tablets, chewable tablets, and oral granulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionCardinal HealthREPACK2012-05-032551545029, 551545028montelukast Oral Tablet
32da038cf6-cfad-43a4-ab8e-d81d028d6087 (view SPL)These highlights do not include all the information needed to use Montelukast Sodium safely and effectively. See full prescribing information for Montelukast Sodium. Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionTorrent Pharmaceuticals LimitedManufacture2014-01-206136680079
33e8d9021d-73aa-4c96-8b8a-e90069e78555 (view SPL)These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR (montelukast sodium) Tablets, Chewable Tablets, and Oral GranulesInitial U.S. Approval: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-161548684630, 548684847, 548683283montelukast Oral Tablet
34ed2caffa-a75c-1c27-ae30-2d8280eaea7d (view SPL)These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable TabletsInitial U.S. approval: 1998 ---------RECENT MAJOR CHANGES--------------- Warnings and Precautions Neuropsychiatric Events (5.4) 03/2013prescriptionHuman PrescriptionAvkare, Inc.2015-10-016422910622, 422910623, 422910621montelukast Oral Tablet
35fb1b2e4e-a840-447b-b943-ad0b6acc32b5 (view SPL)These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium.Montelukast Sodium TabletsMontelukast Sodium Chewable TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-191680840864, 680840875montelukast Oral Tablet

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