← FDA Drug Approvals (Drugs@FDA)
NUCYNTA
NDA · New Drug Application · Sponsor: COLLEGIUM PHARM INC · Approved 2008-11-20
Drug application
- FDA Application #
NDA022304
- Application type
- New Drug Application
- Brand name
- NUCYNTA
- Generic name
- TAPENTADOL HYDROCHLORIDE
- Active ingredients
- TAPENTADOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- COLLEGIUM PHARM INC
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- First approval
- 2008-11-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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