FDA.reportPublic FDA data

Application 216540

Type
NDA
Sponsor
BRIDGEBIO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATTRUBYACORAMIDIS HYDROCHLORIDETABLET;ORALEQ 356MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N216540-001ATTRUBYACORAMIDIS HYDROCHLORIDEEQ 356MG BASETABLET / ORALRLD, RS2024-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216540-001103986812031-05-05Drug product2024-12-18
N216540-001108427772031-05-05U-40462024-12-18
N216540-00188777952031-05-05Drug product2024-12-18
N216540-00191692142031-05-05U-4046Drug product2024-12-18
N216540-00196428382031-05-05Drug substance, Drug product2024-12-18
N216540-00199138262031-05-05U-40462024-12-18
N216540-001105134972038-02-16Drug substance2024-12-18
N216540-001119198652038-02-16U-40462024-12-18
N216540-001110586682039-03-22U-40462024-12-18
N216540-001120704492039-03-22U-40462024-12-18
N216540-001112600472039-08-16Drug product2024-12-18
N216540-001120050432039-08-16U-4046Drug product2024-12-18
N216540-001125392902039-08-16Drug product2026-02-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216540-001NCE2029-11-22
N216540-001ODE-5062031-11-22

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
2026-09-14 22:38:342026-08N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-222680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N216540-001103986812031-05-05Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001108427772031-05-05U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00188777952031-05-05Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00191692142031-05-05U-4046Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00196428382031-05-05Drug substance, Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00199138262031-05-05U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001105134972038-02-16Drug substance2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001119198652038-02-16U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001110586682039-03-22U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001120704492039-03-22U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001112600472039-08-16Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001120050432039-08-16U-4046Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001125392902039-08-16Drug product2026-02-2784e616aacf4f…
2026-08-18 06:07:402026-07N216540-001103986812031-05-05Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001108427772031-05-05U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00188777952031-05-05Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00191692142031-05-05U-4046Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00196428382031-05-05Drug substance, Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00199138262031-05-05U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001105134972038-02-16Drug substance2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001119198652038-02-16U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001110586682039-03-22U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001120704492039-03-22U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001112600472039-08-16Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001120050432039-08-16U-4046Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001125392902039-08-16Drug product2026-02-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216540-001103986812031-05-05Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001108427772031-05-05U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00188777952031-05-05Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00191692142031-05-05U-4046Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00196428382031-05-05Drug substance, Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00199138262031-05-05U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001105134972038-02-16Drug substance2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001119198652038-02-16U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001110586682039-03-22U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001120704492039-03-22U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001112600472039-08-16Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001120050432039-08-16U-4046Drug product2024-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001103986812031-05-05Drug product2024-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001108427772031-05-05U-40462024-12-1831067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N216540-001NCE2029-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N216540-001ODE-5062031-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N216540-001NCE2029-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001ODE-5062031-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216540-001NCE2029-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001ODE-5062031-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001NCE2029-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001ODE-5062031-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N216540-001NCE2029-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216540-001ODE-5062031-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216540-001NCE2029-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216540-001ODE-5062031-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216540-001NCE2029-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216540-001ODE-5062031-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216540-001NCE2029-11-2203ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216540-001NCE2029-11-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216540-001ODE-5062031-11-22a50c72e98297…

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
AttrubyACORAMIDIS HYDROCHLORIDEBridgeBio Pharma, Inc.913552ef-875d-4cb7-bf05-a7d20a394c382026-06-29Adverse reactionsExact identifier
application applno (NDA): 216540
application number: NDA216540

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80658ORIG 2024-12-20
80425ORIG 2024-11-26
80330ORIG 2024-11-25