approval · primary record
METHYLPHENIDATE HYDROCHLORIDE
FDA · NDA · 2025-09-23
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Action date | 2025-09-23 |
| Brand | RELEXXII |
| Sponsor | OSMOTICA PHARM US |
| Route | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-28T02:34:59.785Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: FDA:METHYLPHENIDATE HYDROCHLORIDE:2025-09-23
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