approval · primary record
METHYLPHENIDATE HYDROCHLORIDE
7 approval events · latest 2026-08-20
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-08-20 |
| Approval events | 7 |
| Brand | JORNAY PM |
| Sponsor | IRONSHORE PHARMS |
| Route | ORAL |
Approval history
7 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-08-20 | FDA | NDA | JORNAY PM | IRONSHORE PHARMS | ORAL |
| 2026-04-10 | FDA | NDA | CONCERTA | JANSSEN PHARMS | ORAL |
| 2026-03-10 | FDA | NDA | QUILLICHEW ER | NEXTWAVE PHARMS | ORAL |
| 2026-03-09 | FDA | NDA | QUILLIVANT XR | NEXTWAVE | ORAL |
| 2025-09-23 | FDA | NDA | APTENSIO XR | RHODES PHARMS | ORAL |
| 2025-02-04 | FDA | NDA | RITALIN | SANDOZ | ORAL |
| 2025-01-08 | FDA | NDA | METHYLIN | SPECGX LLC | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:29:52.518Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:methylphenidate-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Methylphenidate Hydrochloride · compound