FDA.reportPublic FDA data

Application 218230

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLUJEPAGEPOTIDACIN MESYLATETABLET;ORALEQ 750MG 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
N218230-001BLUJEPAGEPOTIDACIN MESYLATEEQ 750MG BASETABLET / ORALRLD, RS2025-03-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218230-00183895242029-02-12U-4166Drug substance, Drug product2025-04-21
N218230-001107025212035-08-20U-43612025-12-23
N218230-001112296462035-08-20U-43612025-12-23
N218230-001125288092042-12-13U-4361Drug substance, Drug product2026-02-12
N218230-001125288092042-12-13U-4408Drug substance, Drug product2026-02-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218230-001I-9782028-12-11
N218230-001NCE2030-03-25
N218230-001GAIN2035-03-25

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
2026-02-19 14:30 UTC2026-02N218230-001BLUJEPAEQ 750MG BASETABLET / ORALRLD, RS2025-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218230-001BLUJEPAEQ 750MG BASETABLET / ORALRLD, RS2025-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N218230-001BLUJEPAEQ 750MG BASETABLET / ORALRLD, RS2025-03-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001BLUJEPAEQ 750MG BASETABLET / ORALRLD, RS2025-03-25a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218230-00183895242029-02-12U-4166Drug substance, Drug product2025-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218230-001107025212035-08-20U-43612025-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218230-001112296462035-08-20U-43612025-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218230-00183895242029-02-12U-4166Drug substance, Drug product2025-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N218230-00183895242029-02-12U-4166Drug substance, Drug product2025-04-216a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-00183895242029-02-12U-4166Drug substance, Drug product2025-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001107025212035-08-20U-43612025-12-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001112296462035-08-20U-43612025-12-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001125288092042-12-13U-4361Drug substance, Drug product2026-02-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001125288092042-12-13U-4408Drug substance, Drug product2026-02-12a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N218230-001I-9782028-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218230-001NCE2030-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218230-001GAIN2035-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218230-001NCE2030-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218230-001GAIN2035-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N218230-001NCE2030-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218230-001GAIN2035-03-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001I-9782028-12-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001NCE2030-03-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218230-001GAIN2035-03-25a50c72e98297…

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
BlujepaGEPOTIDACINGlaxoSmithKline LLC80b57cfe-7819-4d95-a57d-014af42f118d2026-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 218230
application number: NDA218230

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84969SUPPL 2026-02-09
84398SUPPL 2025-12-12
84388SUPPL 2025-12-11
81946ORIG 2025-04-21
81744ORIG 2025-03-27
81707ORIG 2025-03-25