← FDA Drug Approvals (Drugs@FDA)
ROXICODONE
NDA · New Drug Application · Sponsor: SPECGX LLC · Approved 2000-08-31
Drug application
- FDA Application #
NDA021011- Application type
- New Drug Application
- Brand name
- ROXICODONE
- Generic name
- OXYCODONE HYDROCHLORIDE
- Active ingredients
- OXYCODONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SPECGX LLC
- Manufacturer
- SpecGx LLC
- First approval
- 2000-08-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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