← FDA Drug Approvals (Drugs@FDA)
SUBVENITE
NDA · New Drug Application · Sponsor: OWP PHARMS · Approved 2025-09-16
Drug application
- FDA Application #
NDA218879- Application type
- New Drug Application
- Brand name
- SUBVENITE
- Generic name
- LAMOTRIGINE
- Active ingredients
- LAMOTRIGINE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- OWP PHARMS
- Manufacturer
- OWP Pharmaceuticals, Inc.
- First approval
- 2025-09-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown