← FDA Drug Approvals (Drugs@FDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PLATINUM · Approved 2021-11-23
Drug application
- FDA Application #
ANDA078992- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Generic name
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active ingredients
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PLATINUM
- Manufacturer
- Par Health USA, LLC
- First approval
- 2021-11-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown