FDA.reportPublic FDA data

Application 020768

Type
NDA
Sponsor
IPR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOMIGZOLMITRIPTANTABLET;ORAL2.5MGYesNo
002ZOMIGZOLMITRIPTANTABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-0671ZolmitriptanZolmitriptanImpax GenericsNDACurrent
0115-0672ZolmitriptanZolmitriptanImpax GenericsNDACurrent
64896-671ZOMIGZolmitriptanImpax Specialty PharmaNDACurrent
64896-671ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-671ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-671ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-672ZOMIGZolmitriptanImpax Specialty PharmaNDACurrent
64896-672ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-672ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
64896-672ZOMIGZolmitriptanAmneal PharmaceuticalsNDACurrent
68258-7103ZOMIGZolmitriptanDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57075SUPPL2018-12-31
57030SUPPL2018-12-26
35311SUPPL2012-09-18
25756SUPPL2012-09-18
13387SUPPL2012-09-18
3305SUPPL2012-09-18
35310SUPPL2010-08-19
3304SUPPL2010-08-16
20926ORIG2010-01-29
20927SUPPL2008-02-19
23598ORIG2007-01-17
13386SUPPL2004-11-19
3302SUPPL2004-11-19
3303SUPPL2004-01-14
3301SUPPL2003-06-08
25755SUPPL2002-10-09
25754SUPPL2002-01-29
63742SUPPL1900-01-01
52231SUPPL1900-01-01
52230SUPPL1900-01-01
52229SUPPL1900-01-01
52228SUPPL1900-01-01
52227SUPPL1900-01-01