FDA.reportPublic FDA data

Application 217645

Type
NDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONYDA XRCLONIDINE HYDROCHLORIDESUSPENSION, EXTENDED RELEASE;ORAL0.1MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N217645-001ONYDA XRCLONIDINE HYDROCHLORIDE0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217645-00180626672029-03-29Drug product2024-06-12
N217645-001119186892041-07-28U-3944Drug product2024-06-12
N217645-001125760322041-07-28U-23572026-03-27

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
2026-08-18 06:07:402026-07N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-241e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217645-001ONYDA XR0.1MG/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2024-05-24a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N217645-00180626672029-03-29Drug product2024-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N217645-001119186892041-07-28U-3944Drug product2024-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07N217645-001125760322041-07-28U-23572026-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217645-00180626672029-03-29Drug product2024-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217645-001119186892041-07-28U-3944Drug product2024-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217645-00180626672029-03-29Drug product2024-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217645-001119186892041-07-28U-3944Drug product2024-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N217645-00180626672029-03-29Drug product2024-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217645-001119186892041-07-28U-3944Drug product2024-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217645-00180626672029-03-29Drug product2024-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217645-001119186892041-07-28U-3944Drug product2024-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217645-00180626672029-03-29Drug product2024-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217645-001119186892041-07-28U-3944Drug product2024-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217645-00180626672029-03-29Drug product2024-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217645-001119186892041-07-28U-3944Drug product2024-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217645-00180626672029-03-29Drug product2024-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217645-001119186892041-07-28U-3944Drug product2024-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217645-00180626672029-03-29Drug product2024-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217645-001119186892041-07-28U-3944Drug product2024-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217645-00180626672029-03-29Drug product2024-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217645-001119186892041-07-28U-3944Drug product2024-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217645-00180626672029-03-29Drug product2024-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N217645-001119186892041-07-28U-3944Drug product2024-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217645-00180626672029-03-29Drug product2024-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217645-001119186892041-07-28U-3944Drug product2024-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217645-00180626672029-03-29Drug product2024-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217645-001119186892041-07-28U-3944Drug product2024-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217645-00180626672029-03-29Drug product2024-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217645-001119186892041-07-28U-3944Drug product2024-06-121e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217645-00180626672029-03-29Drug product2024-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217645-001119186892041-07-28U-3944Drug product2024-06-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217645-001125760322041-07-28U-23572026-03-27a50c72e98297…

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
ONYDA XRCLONIDINE HYDROCHLORIDENextWave Pharmaceuticals, Inc4a15c850-9da5-4bdc-a34d-7f740a6149b72025-04-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 217645
application number: NDA217645

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82186SUPPL 2025-05-14
82257SUPPL 2025-05-07
80543SUPPL 2024-12-10
80537SUPPL 2024-12-09
79731ORIG 2024-09-25
78564ORIG 2024-05-28
78560ORIG 2024-05-28