← FDA Drug Approvals (Drugs@FDA)
REMERON SOLTAB
NDA · New Drug Application · Sponsor: ORGANON USA ORGANON · Approved 2001-01-12
Drug application
- FDA Application #
NDA021208- Application type
- New Drug Application
- Brand name
- REMERON SOLTAB
- Generic name
- MIRTAZAPINE
- Active ingredients
- MIRTAZAPINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ORGANON USA ORGANON
- Manufacturer
- Organon LLC
- First approval
- 2001-01-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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