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HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
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 |