FDA.reportPublic FDA data

Application 019715

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPENTUMOLSALAZINE SODIUMCAPSULE;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-6860Dipentumolsalazine sodiumMEDA PharmaceuticalsNDACurrent
0037-6860Dipentumolsalazine sodiumMeda PharmaceuticalsNDACurrent
0037-6860Dipentumolsalazine sodiumMeda Pharmaceuticals Inc.NDACurrent
0037-6860Dipentumolsalazine sodiumMeda PharmaceuticalsNDACurrent
0037-6860Dipentumolsalazine sodiumMEDA PharmaceuticalsNDACurrent
0037-6860Dipentumolsalazine sodiumMeda Pharmaceuticals Inc.NDACurrent
0037-6860Dipentumolsalazine sodiumMeda PharmaceuticalsNDACurrent
0037-6860Dipentumolsalazine sodiumMeda Pharmaceuticals Inc.NDACurrent
68151-0312Dipentumolsalazine sodiumCarilion Materials ManagementNDACurrent
68151-3120Dipentumolsalazine sodiumCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79269SUPPL 2024-08-02
79258SUPPL 2024-07-31
75941SUPPL 2023-10-25
75940SUPPL 2023-10-25
72641SUPPL2022-11-17
72631SUPPL2022-11-17
69208SUPPL2021-11-02
69201SUPPL2021-11-02
67948SUPPL2021-06-29
67921SUPPL2021-06-28
64883SUPPL2020-10-08
64878SUPPL2020-10-08
1523SUPPL2009-11-12
33878SUPPL2009-08-13
1522SUPPL2007-07-16
1521SUPPL2002-08-09
1520SUPPL2002-01-18