almotriptan Oral Tablet

Brand(s)
Axert
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Patriot Pharmaceuticals, Llc (2015-07-09)
Oldest Current Product
2006-02-09
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ALMOTRIPTAN
FDAOB
ORAL\TABLET\ALMOTRIPTAN MALATE
SPL Active
ORAL\TABLET, COATED\ALMOTRIPTAN MALATE
ORAL\TABLET, FILM COATED\ALMOTRIPTAN MALATE
SPL Moiety
ORAL\TABLET, COATED\ALMOTRIPTAN
ORAL\TABLET, FILM COATED\ALMOTRIPTAN

product(s) by strength(s)

almotriptan 12.5 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101470961NDAPatriot Pharmaceuticals, Llc2015-07-07ALMOTRIPTAN MALATEORALTABLET, COATEDNDA0210019129bb95-7846-4ed7-bd03-0c17d8963447

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935261ANDATeva Pharmaceuticals Usa Inc2015-07-07ALMOTRIPTAN MALATEORALTABLET, FILM COATEDANDA078027c41a4579-9db0-402b-81b1-0adf5b3978c3
2003785246ANDAMylan Pharmaceuticals Inc.2015-11-10ALMOTRIPTAN MALATEORALTABLET, FILM COATEDANDA20517135617039-9f33-401b-bac3-8f85c65fa2c7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685527AxertNDAPhysicians Total Care, Inc.2006-02-09ALMOTRIPTAN MALATEORALTABLET, COATED000622085NDA021001886c13fa-4547-4411-88aa-8e23a7a698f6

almotriptan 6.25 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101470962NDAPatriot Pharmaceuticals, Llc2015-07-07ALMOTRIPTAN MALATEORALTABLET, COATEDNDA0210019129bb95-7846-4ed7-bd03-0c17d8963447

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935260ANDATeva Pharmaceuticals Usa Inc2015-07-07ALMOTRIPTAN MALATEORALTABLET, FILM COATEDANDA078027c41a4579-9db0-402b-81b1-0adf5b3978c3
2003785245ANDAMylan Pharmaceuticals Inc.2015-11-10ALMOTRIPTAN MALATEORALTABLET, FILM COATEDANDA20517135617039-9f33-401b-bac3-8f85c65fa2c7

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA078027ALMOTRIPTAN MALATETEVA PHARMACEUTICALS USA2015-07-07ANDA078027_001, ANDA078027_002
2ANDA205171ALMOTRIPTAN MALATEMYLAN PHARMACEUTICALS INC2015-11-09ANDA205171_001, ANDA205171_002
3NDA021001AXERTJANSSEN PHARMACEUTICALS INC2001-05-07p5565447, TREATMENT OF MIGRAINE, SUBSTANCENDA021001_001, NDA021001_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078027_001RXALMOTRIPTAN MALATE (EQ 6.25MG BASE)ORALTABLETFalseAB2015-07-07ALMOTRIPTAN MALATE
2ANDA078027_002RXALMOTRIPTAN MALATE (EQ 12.5MG BASE)ORALTABLETFalseAB2015-07-07ALMOTRIPTAN MALATE
3ANDA205171_001RXALMOTRIPTAN MALATE (EQ 6.25MG BASE)ORALTABLETFalseAB2015-11-09ALMOTRIPTAN MALATE
4ANDA205171_002RXALMOTRIPTAN MALATE (EQ 12.5MG BASE)ORALTABLETFalseAB2015-11-09ALMOTRIPTAN MALATE
5NDA021001_001RXALMOTRIPTAN MALATE (EQ 6.25MG BASE)ORALTABLETFalseAB2001-05-07AXERT
6NDA021001_002RXALMOTRIPTAN MALATE (EQ 12.5MG BASE)ORALTABLETTrueAB2001-05-07AXERT

patent(s)

#idexpiration dateapplication(s)
1p5565447 (view patent)2015-05-07NDA021001

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
135617039-9f33-401b-bac3-8f85c65fa2c7 (view SPL)These highlights do not include all the information needed to use ALMOTRIPTAN TABLETS safely and effectively. See full prescribing information for ALMOTRIPTAN TABLETS. ALMOTRIPTAN tablets USP, for oral use Initial U.S. Approval: 2001prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-09-211003785245, 003785246
2886c13fa-4547-4411-88aa-8e23a7a698f6 (view SPL)These highlights do not include all the information needed to use AXERT safely and effectively. See full prescribing information for AXERT. AXERT (almotriptan malate) Tablets for Oral Use Initial U.S. Approval: 2001prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-10-102548685527
39129bb95-7846-4ed7-bd03-0c17d8963447 (view SPL)These highlights do not include all the information needed to use Almotriptan Malate tablets safely and effectively. See full prescribing information for Almotriptan Malate tablets. Almotriptan Malate tablets for Oral UseInitial U.S. Approval: 2001prescriptionHuman PrescriptionPatriot Pharmaceuticals, LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-07-091101470961, 101470962
4a8479ec0-204e-11e1-aa3f-a3c74724019b (view SPL)These highlights do not include all the information needed to use AXERT safely and effectively. See full prescribing information for AXERT. AXERT (almotriptan malate) Tablets for Oral Use Initial U.S. Approval: 2001prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-08-133504580210, 504580211
5c41a4579-9db0-402b-81b1-0adf5b3978c3 (view SPL)These highlights do not include all the information needed to use almotriptan malate tablets safely and effectively. See full prescribing information for almotriptan malate tablets. ALMOTRIPTAN malate tablets for oral useInitial U.S. Approval: 2001prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-162000935260, 000935261

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