FDA.reportPublic FDA data

Application 019618

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROWASAMESALAMINEENEMA;RECTAL4GM/60MLYesYes
002SFROWASAMESALAMINEENEMA;RECTAL4GM/60MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-0022sfRowasamesalamineMeda Pharmaceuticals Inc.NDACurrent
0037-0022sfRowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0022sfRowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0022sfRowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0022sfRowasamesalamineMeda Pharmaceuticals Inc.NDACurrent
0037-0022sfRowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0066RowasamesalamineMeda Pharmaceuticals Inc.NDACurrent
0037-0066RowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0066RowasamesalamineMeda Pharmaceuticals Inc.NDACurrent
0037-0066RowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0066RowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0066RowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0066RowasamesalamineMeda Pharmaceuticals Inc.NDACurrent
0037-0066RowasamesalamineMeda PharmaceuticalsNDACurrent
0037-0066RowasamesalamineMeda PharmaceuticalsNDACurrent
62559-420MesalamineMesalamineANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-420MesalamineMesalamineANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-420MesalamineMesalamineANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-420MesalamineMesalamineANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79267SUPPL 2024-08-02
79257SUPPL 2024-07-31
75925SUPPL 2023-10-25
72640SUPPL2022-11-17
72632SUPPL2022-11-17
69209SUPPL2021-11-02
69202SUPPL2021-11-02
67949SUPPL2021-06-29
67923SUPPL2021-06-28
64867SUPPL2020-10-07
64792SUPPL2020-10-02
49137SUPPL2017-07-28
49122SUPPL2017-07-28
11565SUPPL2015-05-26
17488SUPPL2008-06-24
1421SUPPL2006-01-06