← FDA Drug Approvals (Drugs@FDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ADARE PHARMS INC · Approved 2018-10-09
Drug application
- FDA Application #
ANDA210279- 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
- ADARE PHARMS INC
- Manufacturer
- Lannett Company, Inc.
- First approval
- 2018-10-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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