Home Applications 215401 Application 215401
Type NDA
Sponsor NOVEN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XELSTRYM DEXTROAMPHETAMINE SYSTEM; TRANSDERMAL 4.5MG/9HR No No 002 XELSTRYM DEXTROAMPHETAMINE SYSTEM; TRANSDERMAL 9MG/9HR No No 003 XELSTRYM DEXTROAMPHETAMINE SYSTEM;TRANSDERMAL 13.5MG/9HR No No 004 XELSTRYM DEXTROAMPHETAMINE SYSTEM;TRANSDERMAL 18.5MG/9HR No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215401-001 XELSTRYM DEXTROAMPHETAMINE 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 N215401-002 XELSTRYM DEXTROAMPHETAMINE 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 N215401-003 XELSTRYM DEXTROAMPHETAMINE 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 N215401-004 XELSTRYM DEXTROAMPHETAMINE 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215401-001 9456993 2033-10-24 U-3340 Drug product 2022-04-14 N215401-001 9474722 2033-10-24 Drug product 2022-04-14 N215401-001 12678504 2034-03-12 U-4583 Drug product 2026-08-10 N215401-001 11559501 2042-01-06 Drug product 2023-02-17 N215401-002 9456993 2033-10-24 U-3340 Drug product 2022-04-14 N215401-002 9474722 2033-10-24 Drug product 2022-04-14 N215401-002 12678504 2034-03-12 U-4583 Drug product 2026-08-10 N215401-002 11559501 2042-01-06 Drug product 2023-02-17 N215401-003 9456993 2033-10-24 U-3340 Drug product 2022-04-14 N215401-003 9474722 2033-10-24 Drug product 2022-04-14 N215401-003 12678504 2034-03-12 U-4583 Drug product 2026-08-10 N215401-003 11559501 2042-01-06 Drug product 2023-02-17 N215401-004 9456993 2033-10-24 U-3340 Drug product 2022-04-14 N215401-004 9474722 2033-10-24 Drug product 2022-04-14 N215401-004 12678504 2034-03-12 U-4583 Drug product 2026-08-10 N215401-004 11559501 2042-01-06 Drug product 2023-02-17
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 4 · 132 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 2026-10-15 13:18:30 2026-09 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215401-001 XELSTRYM 4.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215401-002 XELSTRYM 9MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215401-003 XELSTRYM 13.5MG/9HR SYSTEM / TRANSDERMAL RLD 2022-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215401-004 XELSTRYM 18MG/9HR SYSTEM / TRANSDERMAL RLD, RS 2022-03-22 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 18 · 696 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 N215401-001 9456993 2033-10-24 U-3340 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-001 9474722 2033-10-24 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-001 12678504 2034-03-12 U-4583 Drug product 2026-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-001 11559501 2042-01-06 Drug product 2023-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-002 9456993 2033-10-24 U-3340 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-002 9474722 2033-10-24 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-002 12678504 2034-03-12 U-4583 Drug product 2026-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-002 11559501 2042-01-06 Drug product 2023-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-003 9456993 2033-10-24 U-3340 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-003 9474722 2033-10-24 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-003 12678504 2034-03-12 U-4583 Drug product 2026-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-003 11559501 2042-01-06 Drug product 2023-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-004 9456993 2033-10-24 U-3340 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-004 9474722 2033-10-24 Drug product 2022-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-004 12678504 2034-03-12 U-4583 Drug product 2026-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215401-004 11559501 2042-01-06 Drug product 2023-02-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215401-001 9456993 2033-10-24 U-3340 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-001 9474722 2033-10-24 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-001 12678504 2034-03-12 U-4583 Drug product 2026-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-001 11559501 2042-01-06 Drug product 2023-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-002 9456993 2033-10-24 U-3340 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-002 9474722 2033-10-24 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-002 12678504 2034-03-12 U-4583 Drug product 2026-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-002 11559501 2042-01-06 Drug product 2023-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-003 9456993 2033-10-24 U-3340 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-003 9474722 2033-10-24 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-003 12678504 2034-03-12 U-4583 Drug product 2026-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-003 11559501 2042-01-06 Drug product 2023-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-004 9456993 2033-10-24 U-3340 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-004 9474722 2033-10-24 Drug product 2022-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-004 12678504 2034-03-12 U-4583 Drug product 2026-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215401-004 11559501 2042-01-06 Drug product 2023-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215401-001 9456993 2033-10-24 U-3340 Drug product 2022-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-001 9474722 2033-10-24 Drug product 2022-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-001 12678504 2034-03-12 U-4583 Drug product 2026-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-001 11559501 2042-01-06 Drug product 2023-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-002 9456993 2033-10-24 U-3340 Drug product 2022-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-002 9474722 2033-10-24 Drug product 2022-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-002 12678504 2034-03-12 U-4583 Drug product 2026-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215401-002 11559501 2042-01-06 Drug product 2023-02-17 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 108 observed states.
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 · 2 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68968-0205 XELSTRYM DEXTROAMPHETAMINE Noven Therapeutics, LLC NDA Current 68968-0210 XELSTRYM DEXTROAMPHETAMINE Noven Therapeutics, LLC NDA Current 68968-0215 XELSTRYM DEXTROAMPHETAMINE Noven Therapeutics, LLC NDA Current 68968-0220 XELSTRYM DEXTROAMPHETAMINE Noven Therapeutics, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 83513 SUPPL 2025-09-25 83512 SUPPL 2025-09-25 83465 SUPPL 2025-09-25 80467 SUPPL 2024-12-02 80465 SUPPL 2024-12-02 75807 SUPPL 2023-10-17 71833 SUPPL 2022-08-17 71817 SUPPL 2022-08-17 70994 ORIG 2022-05-04 70602 ORIG 2022-03-25 70589 ORIG 2022-03-23