← FDA Drug Approvals (Drugs@FDA)
LUVOX
NDA · New Drug Application · Sponsor: ANI PHARMS · Approved 2007-12-20
Drug application
- FDA Application #
NDA021519- Application type
- New Drug Application
- Brand name
- LUVOX
- Generic name
- FLUVOXAMINE MALEATE
- Active ingredients
- FLUVOXAMINE MALEATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ANI PHARMS
- Manufacturer
- ANI Pharmaceuticals, Inc.
- First approval
- 2007-12-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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