Application 207960
- Type
- NDA
- Sponsor
- NEXTWAVE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 20MG | Yes | No |
| 002 | QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 30MG | Yes | No |
| 003 | QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 40MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207960-001 | QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | |
| N207960-002 | QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | |
| N207960-003 | QUILLICHEW ER | METHYLPHENIDATE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N207960-001 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | |
| N207960-001 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | |
| N207960-001 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 |
| N207960-001 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | |
| N207960-001 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 |
| N207960-001 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | |
| N207960-001 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | |
| N207960-001 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 |
| N207960-001 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 |
| N207960-001 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 |
| N207960-002 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | |
| N207960-002 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | |
| N207960-002 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 |
| N207960-002 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | |
| N207960-002 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 |
| N207960-002 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | |
| N207960-002 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | |
| N207960-002 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 |
| N207960-002 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 |
| N207960-002 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 |
| N207960-003 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | |
| N207960-003 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | |
| N207960-003 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 |
| N207960-003 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | |
| N207960-003 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 |
| N207960-003 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | |
| N207960-003 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | |
| N207960-003 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 |
| N207960-003 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 |
| N207960-003 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 |
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 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207960-002 | QUILLICHEW ER | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207960-003 | QUILLICHEW ER | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD, RS | 2015-12-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207960-001 | QUILLICHEW ER | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE / ORAL | RLD | 2015-12-04 | 1e350fbaab3a… |
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 | N207960-001 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-001 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-002 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207960-003 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 8202537 | 2027-03-15 | Drug product | 2015-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 8287903 | 2031-02-15 | Drug product | 2015-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 10857143 | 2033-08-14 | U-2993 | Drug product | 2020-12-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 11103494 | 2033-08-14 | Drug product | 2021-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 11103495 | 2033-08-14 | U-2993 | Drug product | 2021-08-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 11633389 | 2033-08-14 | Drug product | 2023-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 8999386 | 2033-08-14 | Drug product | 2015-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 9295642 | 2033-08-14 | U-1827 | Drug product | 2016-04-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 9545399 | 2033-08-14 | U-1827 | Drug product | 2017-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207960-001 | 9844544 | 2033-08-14 | U-2203 | Drug product | 2017-12-21 | 011fe1cb6892… |
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 |
|---|---|---|---|---|---|---|
| QuilliChew ER | METHYLPHENIDATE HYDROCHLORIDE | NextWave Pharmaceuticals, Inc | defc1205-8e90-4b1e-b862-05e4c35c7364 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 207960 NDA207960 24478-074 24478-076 24478-075 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24478-074 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-074 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-075 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-075 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-076 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-076 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-120 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc. | NDA | Current |
| 24478-130 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc. | NDA | Current |
| 24478-140 | QuilliChew ER | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85340 | SUPPL | 2026-03-12 |
| 85339 | SUPPL | 2026-03-12 |
| 83594 | SUPPL | 2025-09-30 |
| 83485 | SUPPL | 2025-09-25 |
| 83483 | SUPPL | 2025-09-25 |
| 75889 | SUPPL | 2023-10-23 |
| 75759 | SUPPL | 2023-10-16 |
| 67940 | SUPPL | 2021-06-29 |
| 67936 | SUPPL | 2021-06-29 |
| 67935 | SUPPL | 2021-06-29 |
| 47496 | SUPPL | 2017-03-08 |
| 47494 | SUPPL | 2017-03-08 |
| 47459 | SUPPL | 2017-03-03 |
| 46843 | SUPPL | 2017-01-17 |
| 46711 | SUPPL | 2017-01-06 |
| 23046 | ORIG | 2016-07-19 |
| 40604 | ORIG | 2015-12-08 |
| 32871 | ORIG | 2015-12-08 |
| 51366 | ORIG | 1900-01-01 |
| 51365 | ORIG | 1900-01-01 |
| 51364 | ORIG | 1900-01-01 |
| 51363 | ORIG | 1900-01-01 |