← FDA Drug Approvals (Drugs@FDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS INC · Approved 2017-07-05
Drug application
- FDA Application #
ANDA203614- 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
- IMPAX LABS INC
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- First approval
- 2017-07-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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