Application 208147

Type
NDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DYANAVEL XRAMPHETAMINESUSPENSION, EXTENDED RELEASE;ORALEQ 2.5MG BASE/MLYesYes

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
N208147-001DYANAVEL XRAMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208147-001100860872027-03-15Drug product2018-10-03
N208147-00185976842027-03-15Drug product2015-10-27
N208147-00187479022027-03-15Drug product2015-10-27
N208147-00188832172027-03-15Drug product2015-10-27
N208147-00196757032027-03-15Drug product2017-06-28
N208147-00180626672029-03-29Drug product2015-10-27
N208147-001115902282036-09-07U-3538Drug product2023-03-08

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-193f01610625f2…
2019-09-15 20:21 UTC2019-09N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N208147-001DYANAVEL XREQ 2.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208147-001DYANAVEL XR2MG/ML;EQ 0.5MG BASE/MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS2015-10-19cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 7 · 269 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208147-001100860872027-03-15Drug product2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208147-00185976842027-03-15Drug product2015-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208147-00187479022027-03-15Drug product2015-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208147-00188832172027-03-15Drug product2015-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208147-00196757032027-03-15Drug product2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208147-00180626672029-03-29Drug product2015-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208147-001115902282036-09-07U-3538Drug product2023-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-001100860872027-03-15Drug product2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-00185976842027-03-15Drug product2015-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-00187479022027-03-15Drug product2015-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-00188832172027-03-15Drug product2015-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-00196757032027-03-15Drug product2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-00180626672029-03-29Drug product2015-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208147-001115902282036-09-07U-3538Drug product2023-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208147-001100860872027-03-15Drug product2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208147-00185976842027-03-15Drug product2015-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208147-00187479022027-03-15Drug product2015-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208147-00188832172027-03-15Drug product2015-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208147-00196757032027-03-15Drug product2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208147-00180626672029-03-29Drug product2015-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208147-001115902282036-09-07U-3538Drug product2023-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-001100860872027-03-15Drug product2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-00185976842027-03-15Drug product2015-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-00187479022027-03-15Drug product2015-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-00188832172027-03-15Drug product2015-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-00196757032027-03-15Drug product2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-00180626672029-03-29Drug product2015-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208147-001115902282036-09-07U-3538Drug product2023-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-001100860872027-03-15Drug product2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-00185976842027-03-15Drug product2015-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-00187479022027-03-15Drug product2015-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-00188832172027-03-15Drug product2015-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-00196757032027-03-15Drug product2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-00180626672029-03-29Drug product2015-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208147-001115902282036-09-07U-3538Drug product2023-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208147-001100860872027-03-15Drug product2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208147-00185976842027-03-15Drug product2015-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208147-00187479022027-03-15Drug product2015-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208147-00188832172027-03-15Drug product2015-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208147-00196757032027-03-15Drug product2017-06-2803ed91905a0d…

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
Dyanavel XRAMPHETAMINENextWave Pharmaceuticals, Incae304b29-0b40-40ec-ad0d-76b742d4a9b92026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208147
application number: NDA208147
ndc (product): 24478-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24478-102Dyanavel XRamphetamineNextWave Pharmaceuticals, IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent
27808-102Dyanavel XRamphetamineTris Pharma IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83494SUPPL 2025-09-25
83493SUPPL 2025-09-25
83451SUPPL 2025-09-25
75786SUPPL 2023-10-17
75768SUPPL 2023-10-16
71212SUPPL2022-06-06
71203SUPPL2022-06-02
70378SUPPL2022-03-02
70377SUPPL2022-03-02
70295SUPPL2022-02-28
57495SUPPL2019-02-08
57492SUPPL2019-02-07
57491SUPPL2019-02-07
48470SUPPL2017-05-22
48469SUPPL2017-05-22
46759SUPPL2017-01-10
46712SUPPL2017-01-06
24534ORIG2016-06-30
23050ORIG2016-06-30
32895ORIG2015-10-22
19986ORIG2015-10-22
51529ORIG1900-01-01
51528ORIG1900-01-01
51527ORIG1900-01-01