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HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | |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| METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | |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| METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 |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| 2026-08 | N021475-001 | METHYLIN | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2003-04-15 | 84e616aacf4f… | |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 | Cranbury Pharmaceuticals, LLC | e817377f-bc72-415a-acd2-7136746b2479 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b77128b3-fce4-4bee-bdad-5fe4af9d612d | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | c87a2000-b75c-41df-8497-7e00a9b41ad4 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 371346d1-ac7e-491c-a010-ad29cb3d567a | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | ec3d9304-13bc-4f0b-bf14-1a1ea824bd91 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride Extended-Release | METHYLPHENIDATE HYDROCHLORIDE | SpecGx LLC | b1b0f2ff-d9df-42ab-b471-226ecf97e075 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Ascend Laboratories, LLC | 8e97c9f3-956c-416a-a7c2-68bb92053ce5 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Accord Healthcare, Inc. | 4f3c91e6-4576-4326-bdab-7d8fb7c09bb8 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 11f4ec97-ed86-48b5-af3a-446b882294cb | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 1da9dc9e-7e8e-457a-93d4-9c2aee434e69 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b9c31526-d486-433c-9b3c-7a12765afe94 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 83e70f8f-18dd-45fc-8bc5-4b8f7f23439e | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | ad3a3865-952e-46cf-8387-1228e2375312 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | ea5a6d4e-60ba-46f3-b314-3c7a970b377d | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Lupin Pharmaceuticals,Inc. | ec8a8896-077d-4dee-9e10-97172512c5ed | 2024-03-21 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Nivagen Pharmaceuticals, Inc. | 4cc16009-44ad-4055-ac76-efa282f1ff47 | 2024-02-26 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 7293dffd-eb01-43d4-b9c4-04f79bec180c | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 213ca0da-dde8-48ee-ac8c-c66558e6f62d | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | b49863bd-20ba-44d5-8dab-96fcbd276a5c | 2024-01-10 | 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 |