FDA.reportPublic FDA data

Application 016885

Type
NDA
Sponsor
HRA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYSODRENMITOTANETABLET;ORAL500MGYesYes

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
N016885-001LYSODRENMITOTANE500MGTABLET / ORALRLD, RS, Approved before 1982

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 UTC2022-10N016885-001LYSODREN500MGTABLET / ORALRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016885-001LYSODREN500MGTABLET / ORALRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016885-001LYSODREN500MGTABLET / ORALRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016885-001LYSODREN500MGTABLET / ORALRLD, RS, Approved before 1982a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LysodrenMITOTANEESTEVE PHARMACEUTICALS, S.A.4046a224-8832-daa2-e063-6294a90a11d72026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016885
application number: NDA016885
LysodrenMITOTANEHRA Pharma Rare Diseasesf0cd76e9-460c-450e-b094-172e636f340a2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016885
application number: NDA016885
ndc (product): 76336-080

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0015-3080LYSODRENMITOTANEE.R. Squibb & Sons, L.L.C.NDACurrent
0015-3080LYSODRENMITOTANEE.R. Squibb & Sons, L.L.C.NDACurrent
76336-080LysodrenmitotaneHRA Pharma Rare DiseasesNDACurrent
76336-080LysodrenmitotaneLaboratoire HRA PharmaNDACurrent
76336-080LysodrenmitotaneHRA Pharma Rare DiseasesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80047SUPPL 2024-10-30
80043SUPPL 2024-10-29
80042SUPPL 2024-10-29
77202SUPPL 2024-01-10
77200SUPPL 2024-01-09
67837SUPPL2021-06-17
67828SUPPL2021-06-16
48357SUPPL2017-05-12
48335SUPPL2017-05-10
13049SUPPL2016-03-15
10932SUPPL2016-03-15
10931SUPPL2013-11-22
513SUPPL2013-11-18
13048SUPPL2009-02-13
10930SUPPL2009-02-12
20068SUPPL2009-01-12
13047SUPPL2003-07-28