Application 216117
- Type
- NDA
- Sponsor
- OSMOTICA PHARM CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 18MG | Yes | No |
| 002 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 27MG | Yes | No |
| 003 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 36MG | Yes | No |
| 004 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 45MG | Yes | No |
| 005 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 54MG | Yes | No |
| 006 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 63MG | Yes | No |
| 007 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 72MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216117-001 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | |
| N216117-002 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | |
| N216117-003 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | |
| N216117-004 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | |
| N216117-005 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | |
| N216117-006 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 63MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | |
| N216117-007 | RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-06-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216117-001 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-001 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-001 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-001 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-001 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-002 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-002 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-002 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-002 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-002 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-003 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-003 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-003 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-003 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-003 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-004 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-004 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-004 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-004 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-004 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-005 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-005 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-005 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-005 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-005 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-006 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-006 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-006 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-006 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-006 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-007 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
| N216117-007 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-007 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | |
| N216117-007 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | |
| N216117-007 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 |
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 | N216117-001 | RELEXXII | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-002 | RELEXXII | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-003 | RELEXXII | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-004 | RELEXXII | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-005 | RELEXXII | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-006 | RELEXXII | 63MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-007 | RELEXXII | 72MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-06-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-001 | RELEXXII | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-002 | RELEXXII | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-003 | RELEXXII | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-004 | RELEXXII | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-005 | RELEXXII | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-006 | RELEXXII | 63MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-007 | RELEXXII | 72MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-06-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-001 | RELEXXII | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-002 | RELEXXII | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-003 | RELEXXII | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-004 | RELEXXII | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-005 | RELEXXII | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-006 | RELEXXII | 63MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216117-007 | RELEXXII | 72MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-06-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-001 | RELEXXII | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-002 | RELEXXII | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-003 | RELEXXII | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-004 | RELEXXII | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-005 | RELEXXII | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-006 | RELEXXII | 63MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216117-007 | RELEXXII | 72MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-06-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-001 | RELEXXII | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-002 | RELEXXII | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-003 | RELEXXII | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-004 | RELEXXII | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-005 | RELEXXII | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-006 | RELEXXII | 63MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216117-007 | RELEXXII | 72MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-06-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216117-001 | RELEXXII | 18MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216117-002 | RELEXXII | 27MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216117-003 | RELEXXII | 36MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216117-004 | RELEXXII | 45MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216117-005 | RELEXXII | 54MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2022-06-23 | 03ed91905a0d… |
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 | N216117-001 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-001 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-001 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-001 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-001 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-002 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-002 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-002 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-002 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-002 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-003 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-003 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-003 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-003 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-003 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-004 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-004 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-004 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-004 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-004 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-005 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-005 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-005 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-005 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-005 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-006 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-006 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-006 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-006 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-006 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-007 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-007 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-007 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-007 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216117-007 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-001 | 10265308 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-001 | 10695336 | 2037-02-03 | U-4032 | 2024-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-001 | 9707217 | 2037-02-03 | Drug product | 2024-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-001 | 9827234 | 2037-02-03 | U-4032 | 2024-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216117-001 | 9855258 | 2037-02-03 | U-4032 | Drug product | 2024-11-18 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | Vertical Pharmaceuticals, LLC | 22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | 216117 NDA216117 68025-089 68025-088 |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Trigen Laboratories, LLC | dd8d7b6e-c23d-4e16-bb53-959e9127ebc6 | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | 216117 NDA216117 13811-711 13811-700 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13811-700 | Methylphenidate Hydrochloride | Methylphenidate hydrochloride | Trigen Laboratories, LLC | NDA | Current |
| 13811-711 | Methylphenidate Hydrochloride | Methylphenidate hydrochloride | Trigen Laboratories, LLC | NDA | Current |
| 68025-088 | RELEXXII | methylphyenidate hydrochloride extended-release | Vertical Pharmaceuticals, LLC | NDA | Current |
| 68025-089 | RELEXXII | methylphyenidate hydrochloride extended-release | Vertical Pharmaceuticals, LLC | NDA | Current |