← FDA Drug Approvals (Drugs@FDA)
METHYLPHENIDATE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPECGX LLC · Approved 2012-12-28
Drug application
- FDA Application #
ANDA202608- 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
- SPECGX LLC
- Manufacturer
- SpecGx LLC
- First approval
- 2012-12-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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