FDA.reportPublic FDA data

Application 019715

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019715-001DIPENTUMOLSALAZINE SODIUM250MGCAPSULE / ORALRLD, RS1990-07-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019715-001DIPENTUM250MGCAPSULE / ORALRLD, RS1990-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019715-001DIPENTUM250MGCAPSULE / ORALRLD, RS1990-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019715-001DIPENTUM250MGCAPSULE / ORALRLD, RS1990-07-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019715-001DIPENTUM250MGCAPSULE / ORALRLD, RS1990-07-31a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DipentumOLSALAZINE SODIUMViatris Specialty LLC8512d0c6-db4e-4673-b3b4-28975c18413f2026-05-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 019715
application number: NDA019715
ndc (product): 0037-6860

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

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