Application 202100
- Type
- NDA
- Sponsor
- NEXTWAVE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUILLIVANT XR | METHYLPHENIDATE HYDROCHLORIDE | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 5MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202100-001 | QUILLIVANT XR | METHYLPHENIDATE HYDROCHLORIDE | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N202100-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | |
| N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | |
| N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 |
| N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 |
| N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 |
| N202100-001 | 8956649 | 2031-02-15 | U-1665 | Drug product | 2015-03-13 |
| N202100-001 | 9040083 | 2031-02-15 | Drug product | 2015-06-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2012-09-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2012-09-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2012-09-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2012-09-27 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2012-09-27 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N202100-001 | QUILLIVANT XR | 5MG/ML | FOR SUSPENSION, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-09-27 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202100-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202100-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202100-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202100-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202100-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202100-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202100-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202100-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202100-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202100-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202100-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N202100-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202100-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202100-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202100-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202100-001 | AB | 1 | 8869cabd3fbd… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202100-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202100-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202100-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202100-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202100-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202100-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202100-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202100-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202100-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202100-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202100-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N202100-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N202100-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N202100-001 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 8956649 | 2031-02-15 | U-1665 | Drug product | 2015-03-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202100-001 | 9040083 | 2031-02-15 | Drug product | 2015-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 8956649 | 2031-02-15 | U-1665 | Drug product | 2015-03-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202100-001 | 9040083 | 2031-02-15 | Drug product | 2015-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 8956649 | 2031-02-15 | U-1665 | Drug product | 2015-03-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202100-001 | 9040083 | 2031-02-15 | Drug product | 2015-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 8956649 | 2031-02-15 | U-1665 | Drug product | 2015-03-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202100-001 | 9040083 | 2031-02-15 | Drug product | 2015-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 8956649 | 2031-02-15 | U-1665 | Drug product | 2015-03-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202100-001 | 9040083 | 2031-02-15 | Drug product | 2015-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | 8062667 | 2029-03-29 | Drug product | 2012-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | 8287903 | 2031-02-15 | Drug product | 2012-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | 8465765 | 2031-02-15 | U-1415 | Drug product | 2013-06-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | 8563033 | 2031-02-15 | U-1415 | Drug product | 2013-11-15 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202100-001 | 8778390 | 2031-02-15 | U-1543 | Drug product | 2014-08-04 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Quillivant XR | METHYLPHENIDATE HYDROCHLORIDE | NextWave Pharmaceuticals, Inc | c2dc2109-44a6-4797-b04e-18761dd9d45a | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 202100 NDA202100 24478-321 24478-322 24478-324 24478-323 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24478-190 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-200 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-205 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-210 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-321 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-321 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-321 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-321 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-322 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-322 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-322 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-322 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-323 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-323 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-323 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-323 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-324 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-324 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-324 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-324 | Quillivant | methylphenidate hydrochloride | NextWave Pharmaceuticals, Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85319 | SUPPL | 2026-03-10 |
| 85318 | SUPPL | 2026-03-10 |
| 83593 | SUPPL | 2025-09-30 |
| 83592 | SUPPL | 2025-09-30 |
| 83484 | SUPPL | 2025-09-25 |
| 83482 | SUPPL | 2025-09-25 |
| 75888 | SUPPL | 2023-10-23 |
| 75760 | SUPPL | 2023-10-16 |
| 67939 | SUPPL | 2021-06-29 |
| 67934 | SUPPL | 2021-06-29 |
| 67933 | SUPPL | 2021-06-29 |
| 47000 | SUPPL | 2017-01-27 |
| 46978 | SUPPL | 2017-01-24 |
| 46842 | SUPPL | 2017-01-17 |
| 46841 | SUPPL | 2017-01-17 |
| 46710 | SUPPL | 2017-01-06 |
| 40119 | SUPPL | 2016-05-17 |
| 32178 | SUPPL | 2016-05-16 |
| 19059 | SUPPL | 2015-07-22 |
| 32177 | SUPPL | 2015-07-14 |
| 40118 | SUPPL | 2015-04-21 |
| 32176 | SUPPL | 2015-04-20 |
| 23956 | ORIG | 2013-12-27 |
| 40117 | SUPPL | 2013-12-17 |
| 9959 | SUPPL | 2013-12-13 |
| 40116 | SUPPL | 2013-08-12 |
| 9958 | SUPPL | 2013-08-12 |
| 43383 | ORIG | 2013-07-08 |
| 24407 | ORIG | 2013-07-08 |
| 19058 | SUPPL | 2013-05-21 |
| 32175 | ORIG | 2012-10-02 |
| 40115 | ORIG | 2012-09-28 |
| 63528 | ORIG | 1900-01-01 |
| 63527 | ORIG | 1900-01-01 |
| 51362 | ORIG | 1900-01-01 |
| 51361 | ORIG | 1900-01-01 |
| 51360 | ORIG | 1900-01-01 |