FDA.reportPublic FDA data

Application 020864

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAXALTRIZATRIPTAN BENZOATETABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002MAXALTRIZATRIPTAN BENZOATETABLET;ORALEQ 10MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0266MAXALTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-0266MAXALTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-0267MAXALTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-0267MAXALTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-0267MAXALTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-0267MAXALTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
21695-956MAXALTrizatriptan benzoateRebel Distributors CorpNDACurrent
78206-142MAXALTrizatriptan benzoateOrganon LLCNDACurrent
78206-142MAXALTrizatriptan benzoateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60194SUPPL2019-10-02
60193SUPPL2019-10-02
26080SUPPL2011-12-21
26079SUPPL2011-12-21
3606SUPPL2011-12-21
3605SUPPL2011-12-21
3603SUPPL2011-12-21
35530SUPPL2011-12-20
35529SUPPL2011-12-20
35527SUPPL2011-12-20
13640SUPPL2011-12-20
13639SUPPL2011-12-20
35528SUPPL2010-08-19
3604SUPPL2010-08-16
21029SUPPL2008-08-01
41766SUPPL2004-04-21
41765SUPPL2004-04-21
41764SUPPL2004-04-15
21028SUPPL2004-04-15
44077ORIG2003-12-12
26078SUPPL2002-04-22
26077SUPPL1999-12-30
41763ORIG1999-04-08
13638ORIG1998-06-29
3602ORIG1998-06-29
64071ORIG1900-01-01
64070ORIG1900-01-01
63555ORIG1900-01-01
63554ORIG1900-01-01
63553ORIG1900-01-01
63552ORIG1900-01-01
63551ORIG1900-01-01
63550ORIG1900-01-01
63549ORIG1900-01-01
63548ORIG1900-01-01