Application 215401
- Type
- NDA
- Sponsor
- NOVEN PHARMS INC
Application Products#
| 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 |
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-001 | XELSTRYM | 4.5MG/9HR | SYSTEM / TRANSDERMAL | RLD | 2022-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-002 | XELSTRYM | 9MG/9HR | SYSTEM / TRANSDERMAL | RLD | 2022-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-003 | XELSTRYM | 13.5MG/9HR | SYSTEM / TRANSDERMAL | RLD | 2022-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-004 | XELSTRYM | 18MG/9HR | SYSTEM / TRANSDERMAL | RLD, RS | 2022-03-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-001 | XELSTRYM | 4.5MG/9HR | SYSTEM / TRANSDERMAL | RLD | 2022-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-002 | XELSTRYM | 9MG/9HR | SYSTEM / TRANSDERMAL | RLD | 2022-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-003 | XELSTRYM | 13.5MG/9HR | SYSTEM / TRANSDERMAL | RLD | 2022-03-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-004 | XELSTRYM | 18MG/9HR | SYSTEM / TRANSDERMAL | RLD, RS | 2022-03-22 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2026-08-18 06:07:40 | 2026-07 | N215401-003 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215401-003 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215401-003 | 12678504 | 2034-03-12 | U-4583 | Drug product | 2026-08-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215401-003 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215401-004 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215401-004 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215401-004 | 12678504 | 2034-03-12 | U-4583 | Drug product | 2026-08-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215401-004 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-001 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-001 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-001 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-002 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-002 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-002 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-003 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-003 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-003 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-004 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-004 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215401-004 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | 8591941 | 2025-10-07 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | 8632802 | 2025-10-07 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | 9034370 | 2025-10-07 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | 8591941 | 2025-10-07 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | 8632802 | 2025-10-07 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | 9034370 | 2025-10-07 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | 9456993 | 2033-10-24 | U-3340 | Drug product | 2022-04-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | 9474722 | 2033-10-24 | Drug product | 2022-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | 11559501 | 2042-01-06 | Drug product | 2023-02-17 | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-001 | NP | 2025-03-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-002 | NP | 2025-03-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-003 | NP | 2025-03-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215401-004 | NP | 2025-03-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215401-001 | NP | 2025-03-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215401-002 | NP | 2025-03-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215401-003 | NP | 2025-03-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215401-004 | NP | 2025-03-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215401-001 | NP | 2025-03-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215401-002 | NP | 2025-03-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215401-003 | NP | 2025-03-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215401-004 | NP | 2025-03-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215401-001 | NP | 2025-03-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215401-002 | NP | 2025-03-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215401-003 | NP | 2025-03-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215401-004 | NP | 2025-03-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215401-001 | NP | 2025-03-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215401-002 | NP | 2025-03-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215401-003 | NP | 2025-03-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215401-004 | NP | 2025-03-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215401-001 | NP | 2025-03-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215401-002 | NP | 2025-03-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215401-003 | NP | 2025-03-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215401-004 | NP | 2025-03-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-001 | NP | 2025-03-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-002 | NP | 2025-03-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-003 | NP | 2025-03-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215401-004 | NP | 2025-03-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-001 | NP | 2025-03-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-002 | NP | 2025-03-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-003 | NP | 2025-03-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215401-004 | NP | 2025-03-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N215401-001 | NP | 2025-03-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215401-002 | NP | 2025-03-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215401-003 | NP | 2025-03-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215401-004 | NP | 2025-03-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215401-001 | NP | 2025-03-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215401-002 | NP | 2025-03-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215401-003 | NP | 2025-03-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215401-004 | NP | 2025-03-22 | 79d66fd596c7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| XELSTRYM | DEXTROAMPHETAMINE | Noven Therapeutics, LLC | 0862f02a-72a8-41cc-8845-57cf4974bb6f | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 215401 NDA215401 68968-0215 68968-0220 68968-0210 68968-0205 |
NDC Listings For This Application#
| 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 |