← FDA Drug Approvals (Drugs@FDA)
METHYLPHENIDATE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2019-09-03
Drug application
- FDA Application #
ANDA211009- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- METHYLPHENIDATE HYDROCHLORIDE
- Generic name
- METHYLPHENIDATE HYDROCHLORIDE
- Active ingredients
- METHYLPHENIDATE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ASCENT PHARMS INC
- Manufacturer
- XLCare Pharmaceuticals, Inc.
- First approval
- 2019-09-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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