FDA.reportPublic FDA data

Application 208794

Type
NDA
Sponsor
LEXICON PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XERMELOTELOTRISTAT ETIPRATETABLET;ORALEQ 250MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208794-001XERMELOTELOTRISTAT ETIPRATEEQ 250MG BASETABLET / ORALRLD, RS2017-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208794-00175538402027-12-11Drug substance2017-03-23
N208794-00179685592027-12-11U-19792017-03-23
N208794-00186530942028-12-19U-19792017-03-23
N208794-00181932042031-02-27Drug substance2017-03-23
N208794-00177094932031-02-28U-1979Drug substance2017-03-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208794-001XERMELOEQ 250MG BASETABLET / ORALRLD, RS2017-02-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208794-00175538402027-12-11Drug substance2017-03-23a50c72e98297…
2026-08-01 22:54:322026-06N208794-00179685592027-12-11U-19792017-03-23a50c72e98297…
2026-08-01 22:54:322026-06N208794-00186530942028-12-19U-19792017-03-23a50c72e98297…
2026-08-01 22:54:322026-06N208794-00181932042031-02-27Drug substance2017-03-23a50c72e98297…
2026-08-01 22:54:322026-06N208794-00177094932031-02-28U-1979Drug substance2017-03-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XermeloTELOTRISTAT ETHYLLexicon Pharmaceuticals, Inc.f9108ac3-ca6e-4faf-9d04-953abb64d0722025-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 208794
application number: NDA208794
ndc (product): 70183-125
XermeloTELOTRISTAT ETHYLLexicon Pharmaceuticals, Inc.f11c21f8-f725-445e-b38e-1e4c5b05bcc62025-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 208794
application number: NDA208794
ndc (product): 70183-125
XermeloTELOTRISTAT ETHYLTerSera Therapeutics LLCa4ac9d62-887c-4c8f-b04d-a5f31cec7c862022-10-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 208794
application number: NDA208794
ndc (product): 70720-125

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
70183-125Xermelotelotristat ethylLexicon Pharmaceuticals, Inc.NDACurrent
70183-125Xermelotelotristat ethylLexicon Pharmaceuticals, Inc.NDACurrent
70183-125Xermelotelotristat ethylLexicon Pharmaceuticals, Inc.NDACurrent
70183-125Xermelotelotristat ethylLexicon Pharmaceuticals, Inc.NDACurrent
70183-125Xermelotelotristat ethylLexicon Pharmaceuticals, Inc.NDACurrent
70183-125Xermelotelotristat ethylLexicon Pharmaceuticals, Inc.NDACurrent
70720-125Xermelotelotristat ethylTerSera Therapeutics LLCNDACurrent
70720-125Xermelotelotristat ethylTerSera Therapeutics LLCNDACurrent
70720-125Xermelotelotristat ethylTerSera Therapeutics LLCNDACurrent
70720-125Xermelotelotristat ethylTerSera Therapeutics LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72163SUPPL2022-09-27
72160SUPPL2022-09-27
65107SUPPL2020-10-30
65044SUPPL2020-10-27
47848ORIG2017-04-04
47434ORIG2017-03-03
47385ORIG2017-03-01