rizatriptan Disintegrating Oral Tablet

Brand(s)
Maxalt
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Jubilant Cadista Pharmaceuticals, Inc. (2015-10-23)
Oldest Current Product
1998-06-29
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\RIZATRIPTAN
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\RIZATRIPTAN BENZOATE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\RIZATRIPTAN BENZOATE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\RIZATRIPTAN

product(s) by strength(s)

rizatriptan 10 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063801MaxaltNDAMerck Sharp & Dohme Corp.1998-06-29RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGNDA020865d93286f5-99f7-4dc5-aa9d-ad73ab8490db
2333420094Macleods Pharmaceuticals LimitedRIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING57ed2505-28f1-4292-b3c3-a49bf0f7c683

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783702ANDAMylan Pharmaceuticals Inc.2012-12-31RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA0781734a88fac9-55f1-4c13-8446-7c7ee9e4a5d2
2007815426ANDASandoz Inc2013-07-02RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA078739f1d08f03-3125-48cb-ac9c-05a36111f9a5
3519910363ANDABreckenridge Pharmaceutical, Inc.2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA203478cd03ee57-0fb8-4ddf-88e8-b1f953a593f8
4572370086ANDACitron Pharma Llc2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA2030622337e102-8df0-4e7f-81d8-5cb86cd48674
5597460446ANDAJubilant Cadista Pharmaceuticals, Inc.2012-03-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA20333442454df9-ffd1-d8c0-f6fb-05198ad8a432
6605053724ANDAApotex Corp2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA20247774d88963-247b-c5a9-d116-7dcb0cc4495d
7658620626ANDAAurobindo Pharma Limited2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA203062a8e37688-426c-4290-933d-54a34ae86000
8684620468ANDAGlenmark Generics Inc., Usa2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA2019144de33a24-db69-444a-b04d-c69ccba57ab2

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684499MaxaltNDAPhysicians Total Care, Inc.2009-12-29RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING000063801NDA0208653756d8e3-7e89-46c7-8723-6fea65363913
2548686397ANDAPhysicians Total Care, Inc.2013-01-29RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING003783702ANDA0781735791a32b-dd80-4b05-a985-3df20129427f
3617860024ANDARemedyrepack Inc.2014-09-09RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING605053724ANDA20247776c94266-8607-4381-b15c-fc0f43c9b606
4631870563ANDAProficient Rx Lp2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING519910363ANDA203478727a3c22-aec9-455d-a3c9-0f5a7bbf6981
5687889550ANDAPreferred Pharmaceuticals, Inc.2013-10-22RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING605053724ANDA2024771e958146-6457-44e4-967f-aec7f599679e

rizatriptan 5 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063800MaxaltNDAMerck Sharp & Dohme Corp.1998-06-29RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGNDA020865d93286f5-99f7-4dc5-aa9d-ad73ab8490db
2333420093Macleods Pharmaceuticals LimitedRIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING57ed2505-28f1-4292-b3c3-a49bf0f7c683

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783701ANDAMylan Pharmaceuticals Inc.2012-12-31RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA0781734a88fac9-55f1-4c13-8446-7c7ee9e4a5d2
2007815425ANDASandoz Inc2013-07-02RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA078739f1d08f03-3125-48cb-ac9c-05a36111f9a5
3519910362ANDABreckenridge Pharmaceutical, Inc.2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA203478cd03ee57-0fb8-4ddf-88e8-b1f953a593f8
4572370085ANDACitron Pharma Llc2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA2030622337e102-8df0-4e7f-81d8-5cb86cd48674
5597460445ANDAJubilant Cadista Pharmaceuticals, Inc.2014-03-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA20333442454df9-ffd1-d8c0-f6fb-05198ad8a432
6605053723ANDAApotex Corp2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA20247774d88963-247b-c5a9-d116-7dcb0cc4495d
7658620625ANDAAurobindo Pharma Limited2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA203062a8e37688-426c-4290-933d-54a34ae86000
8684620467ANDAGlenmark Generics Inc., Usa2013-07-01RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATINGANDA2019144de33a24-db69-444a-b04d-c69ccba57ab2

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900144MaxaltNDAStat Rx Usa Llc1998-06-29RIZATRIPTAN BENZOATEORALTABLET, ORALLY DISINTEGRATING000063800NDA02086508d06e6f-a1d8-4bd9-b851-d63858d55f91

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1ANDA078173RIZATRIPTAN BENZOATEMYLAN PHARMACEUTICALS INC2012-12-31ANDA078173_001, ANDA078173_002
2ANDA078739RIZATRIPTAN BENZOATESANDOZ INC2013-07-01ANDA078739_001, ANDA078739_002
3ANDA201914RIZATRIPTAN BENZOATEGLENMARK GENERICS LTD2013-07-01ANDA201914_001, ANDA201914_002
4ANDA202477RIZATRIPTAN BENZOATEAPOTEX INC2013-07-01ANDA202477_001, ANDA202477_002
5ANDA203062RIZATRIPTAN BENZOATEAUROBINDO PHARMA LTD2013-07-01ANDA203062_001, ANDA203062_002
6ANDA203146RIZATRIPTAN BENZOATEMACLEODS PHARMACEUTICALS LTD2014-09-19ANDA203146_001, ANDA203146_002
7ANDA203334RIZATRIPTAN BENZOATEJUBILANT GENERICS LTD2015-10-16ANDA203334_001, ANDA203334_002
8ANDA203478RIZATRIPTAN BENZOATENATCO PHARMA LTD2013-07-01ANDA203478_001, ANDA203478_002
9NDA020865MAXALT-MLTMERCK AND CO INC1998-06-29PEDIATRIC EXCLUSIVITY [2015-06-16]
NEW PATIENT POPULATION [2014-12-16]
NDA020865_001, NDA020865_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078173_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-12-31RIZATRIPTAN BENZOATE
2ANDA078173_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-12-31RIZATRIPTAN BENZOATE
3ANDA078739_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
4ANDA078739_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
5ANDA201914_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
6ANDA201914_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
7ANDA202477_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
8ANDA202477_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
9ANDA203062_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
10ANDA203062_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
11ANDA203146_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-09-19RIZATRIPTAN BENZOATE
12ANDA203146_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2014-09-19RIZATRIPTAN BENZOATE
13ANDA203334_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-16RIZATRIPTAN BENZOATE
14ANDA203334_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-16RIZATRIPTAN BENZOATE
15ANDA203478_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
16ANDA203478_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-01RIZATRIPTAN BENZOATE
17NDA020865_001RXRIZATRIPTAN BENZOATE (EQ 5MG BASE)ORALTABLET, ORALLY DISINTEGRATINGFalseAB1998-06-29MAXALT-MLT
18NDA020865_002RXRIZATRIPTAN BENZOATE (EQ 10MG BASE)ORALTABLET, ORALLY DISINTEGRATINGTrueAB1998-06-29MAXALT-MLT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
108d06e6f-a1d8-4bd9-b851-d63858d55f91 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-222165900144, 165900461rizatriptan Oral Tablet
21e958146-6457-44e4-967f-aec7f599679e (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. RIZATRIPTAN Benzoate Orally Disintegrating Tablets,Initial U.S. Approval: 1998prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-11-271687889550
32337e102-8df0-4e7f-81d8-5cb86cd48674 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionCitron Pharma Llc2014-06-121572370085, 572370086
43756d8e3-7e89-46c7-8723-6fea65363913 (view SPL)These highlights do not include all the information needed to use MAXALT and MAXALT-MLT safely and effectively. See full prescribing information for MAXALT and MAXALT-MLT.MAXALT (rizatriptan benzoate) tablets, for oral useMAXALT-MLT (rizatriptan benzoate) orally disintegrating tabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-03-142548684499, 548684251rizatriptan Oral Tablet
542454df9-ffd1-d8c0-f6fb-05198ad8a432 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.manufacture2015-10-233597460445, 597460446
64a88fac9-55f1-4c13-8446-7c7ee9e4a5d2 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.RIZATRIPTAN benzoate orally disintegrating tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-195003783701, 003783702
74de33a24-db69-444a-b04d-c69ccba57ab2 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2013-04-304684620467, 684620468
85791a32b-dd80-4b05-a985-3df20129427f (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-02-251548686397
957ed2505-28f1-4292-b3c3-a49bf0f7c683 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.Rizatriptan Benzoate Orally Disintegrating Tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMacleods Pharmaceuticals LimitedANALYSIS, LABEL, MANUFACTURE, PACK2015-07-102333420093, 333420094
106e98aed7-55f8-4ae4-a9d4-58e9d9bae305 (view SPL)These highlights do not include all the information needed to use Rizatriptan Benzoate Tablets and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Rizatriptan Benzoate. Rizatriptan Benzoate Tablets, for oral use Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.API MANUFACTURE, MANUFACTURE, PACK2013-01-242498840578, 498840579, 498840580, 498840581rizatriptan Oral Tablet
11727a3c22-aec9-455d-a3c9-0f5a7bbf6981 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.RIZATRIPTAN Benzoate Orally Disintegrating TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870563
1274d88963-247b-c5a9-d116-7dcb0cc4495d (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. RIZATRIPTAN Benzoate Orally Disintegrating Tablets,Initial U.S. Approval: 1998prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-02-023605053723, 605053724
1376c94266-8607-4381-b15c-fc0f43c9b606 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.RIZATRIPTAN Benzoate Orally Disintegrating Tablets,Initial U.S. Approval: 1998prescriptionHuman PrescriptionRemedyrepack Inc.2014-09-091617860024
14a8e37688-426c-4290-933d-54a34ae86000 (view SPL)These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS. RIZATRIPTAN benzoate orally disintegrating tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-07-162658620625, 658620626
15cd03ee57-0fb8-4ddf-88e8-b1f953a593f8 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.RIZATRIPTAN Benzoate Orally Disintegrating TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.2015-08-284519910362, 519910363
16d93286f5-99f7-4dc5-aa9d-ad73ab8490db (view SPL)These highlights do not include all the information needed to use MAXALT and MAXALT-MLT safely and effectively. See full prescribing information for MAXALT and MAXALT-MLT.MAXALT (rizatriptan benzoate) tablets, for oral useMAXALT-MLT (rizatriptan benzoate) orally disintegrating tabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-03-0621000063800, 000063801, 000060266, 000060267rizatriptan Oral Tablet
17f1d08f03-3125-48cb-ac9c-05a36111f9a5 (view SPL)These highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets.Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionSandoz Inc2013-01-161007815425, 007815426

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