Home Applications 208147 Application 208147
Type NDA
Sponsor TRIS PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DYANAVEL XR AMPHETAMINE SUSPENSION, EXTENDED RELEASE;ORAL EQ 2.5MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208147-001 DYANAVEL XR AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE 2MG/ML;EQ 0.5MG BASE/ML SUSPENSION, EXTENDED RELEASE / ORAL RLD, RS 2015-10-19
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208147-001 10086087 2027-03-15 Drug product 2018-10-03 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 N208147-001 8062667 2029-03-29 Drug product 2015-10-27 N208147-001 11590228 2036-09-07 U-3538 Drug product 2023-03-08
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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N208147-001 DYANAVEL XR 2MG/ML;EQ 0.5MG BASE/ML SUSPENSION, EXTENDED RELEASE / ORAL RLD, RS 2015-10-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208147-001 DYANAVEL XR 2MG/ML;EQ 0.5MG BASE/ML SUSPENSION, EXTENDED RELEASE / ORAL RLD, RS 2015-10-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208147-001 DYANAVEL XR 2MG/ML;EQ 0.5MG BASE/ML SUSPENSION, EXTENDED RELEASE / ORAL RLD, RS 2015-10-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208147-001 DYANAVEL XR 2MG/ML;EQ 0.5MG BASE/ML SUSPENSION, EXTENDED RELEASE / ORAL RLD, RS 2015-10-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 290 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N208147-001 10086087 2027-03-15 Drug product 2018-10-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208147-001 8062667 2029-03-29 Drug product 2015-10-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208147-001 11590228 2036-09-07 U-3538 Drug product 2023-03-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208147-001 10086087 2027-03-15 Drug product 2018-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208147-001 8062667 2029-03-29 Drug product 2015-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208147-001 11590228 2036-09-07 U-3538 Drug product 2023-03-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208147-001 10086087 2027-03-15 Drug product 2018-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208147-001 8062667 2029-03-29 Drug product 2015-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208147-001 11590228 2036-09-07 U-3538 Drug product 2023-03-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208147-001 10086087 2027-03-15 Drug product 2018-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208147-001 8062667 2029-03-29 Drug product 2015-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208147-001 11590228 2036-09-07 U-3538 Drug product 2023-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 10086087 2027-03-15 Drug product 2018-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 8062667 2029-03-29 Drug product 2015-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208147-001 11590228 2036-09-07 U-3538 Drug product 2023-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208147-001 10086087 2027-03-15 Drug product 2018-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208147-001 8597684 2027-03-15 Drug product 2015-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208147-001 8747902 2027-03-15 Drug product 2015-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208147-001 8883217 2027-03-15 Drug product 2015-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208147-001 9675703 2027-03-15 Drug product 2017-06-28 6a471c1ec25d…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24478-102 Dyanavel XR amphetamine NextWave Pharmaceuticals, Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current 27808-102 Dyanavel XR amphetamine Tris Pharma Inc NDA Current