Application 021475
- Type
- NDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021475-001 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | |
| N021475-002 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | |
| N021475-003 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021475-002 | METHYLIN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021475-003 | METHYLIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Northstar Rx LLC | 768bf181-d0d8-49e5-9c87-cacbb069e0b2 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 18024571-4505-6d51-e063-6294a90a1972 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Aurolife Pharma, LLC | 35be77db-fbe3-487e-a220-a08a11aaec28 | 2026-08-13 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 98be5c84-b348-6b8e-e053-2995a90ae4cc | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| methylphenidate hydrochloride CD | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, LLC | e45c75dc-d381-475b-b649-a871c8a36e60 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, LLC | 29f06562-6b6a-4ca6-b62e-d08a45fb3dd4 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, Inc. | 44737c1d-fe75-409e-8a58-591696d3d7aa | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 10aa0dc0-bd0e-4927-a19a-8722d78ad67d | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate | METHYLPHENIDATE HYDROCHLORIDE | KVK-Tech, Inc. | 2cf1b26b-199d-4c7f-ab64-4805a9def2cc | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, Inc. | 3d1f5aff-5d39-496c-b5ed-7f3c70ec641c | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Actavis Pharma, Inc. | 85ef422d-af27-4126-9841-6892af1871d6 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Trigen Laboratories, LLC | c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 22e5ddfa-7264-fbb1-e063-6394a90a6483 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | Janssen Pharmaceuticals, Inc. | 1a88218c-5b18-4220-8f56-526de1a276cd | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Quillivant XR | METHYLPHENIDATE HYDROCHLORIDE | NextWave Pharmaceuticals, Inc | c2dc2109-44a6-4797-b04e-18761dd9d45a | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | cd2c1226-fa19-4734-b62d-89fea73dcb0d | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 5a29687b-5294-4b27-a556-514b092a877d | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | KVK-TECH, INC. | 1bf37f9f-29cf-4b09-9c81-eb369e35a042 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | American Health Packaging | f6581305-cd1e-4171-8c1b-e184c7bde033 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80845 | SUPPL | 2025-01-13 |
| 80826 | SUPPL | 2025-01-10 |
| 80824 | SUPPL | 2025-01-10 |
| 75803 | SUPPL | 2023-10-17 |
| 75761 | SUPPL | 2023-10-16 |
| 67930 | SUPPL | 2021-06-28 |
| 67929 | SUPPL | 2021-06-28 |
| 46832 | SUPPL | 2017-01-13 |
| 46831 | SUPPL | 2017-01-13 |
| 46709 | SUPPL | 2017-01-06 |
| 37031 | SUPPL | 2015-04-21 |
| 5484 | SUPPL | 2015-04-20 |
| 27894 | SUPPL | 2013-12-24 |
| 15556 | SUPPL | 2013-12-17 |
| 37030 | SUPPL | 2013-06-18 |
| 5483 | SUPPL | 2013-06-18 |
| 23665 | ORIG | 2011-12-20 |
| 5482 | SUPPL | 2010-10-20 |
| 37029 | SUPPL | 2010-10-18 |
| 5481 | SUPPL | 2007-06-14 |
| 37028 | SUPPL | 2007-06-12 |
| 5480 | SUPPL | 2006-08-14 |
| 15555 | SUPPL | 2006-08-11 |
| 21682 | ORIG | 2006-07-25 |
| 37027 | ORIG | 2003-04-17 |