FDA.reportPublic FDA data

Application 020865

Type
NDA
Sponsor
MERCK

Application Products#

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ORALLY DISINTEGRATING;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3800MAXALT-MLTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-3800MAXALT-MLTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-3801MAXALT-MLTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-3801MAXALT-MLTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-3801MAXALT-MLTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
0006-3801MAXALT-MLTrizatriptan benzoateMerck Sharp & Dohme Corp.NDACurrent
78206-143MAXALT-MLTrizatriptan benzoateOrganon LLCNDACurrent
78206-143MAXALT-MLTrizatriptan benzoateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60195SUPPL2019-10-02
60192SUPPL2019-10-02
26081SUPPL2011-12-21
3613SUPPL2011-12-21
3612SUPPL2011-12-21
3611SUPPL2011-12-21
3610SUPPL2011-12-21
35534SUPPL2011-12-20
35533SUPPL2011-12-20
35532SUPPL2011-12-20
35531SUPPL2011-12-20
13643SUPPL2011-12-20
13642SUPPL2010-08-19
26082SUPPL2010-08-16
41771SUPPL2008-08-01
41769SUPPL2004-06-09
41770SUPPL2004-04-21
41768SUPPL2004-04-21
21031SUPPL2004-04-21
21030SUPPL2004-04-21
44078ORIG2003-12-12
3609SUPPL2002-04-22
3608SUPPL1999-11-23
41767ORIG1999-04-08
13641ORIG1998-06-29
3607ORIG1998-06-29
53406ORIG1900-01-01
53405ORIG1900-01-01
53404ORIG1900-01-01
53403ORIG1900-01-01
53402ORIG1900-01-01
53401ORIG1900-01-01
53400ORIG1900-01-01
53399ORIG1900-01-01