← FDA Drug Approvals (Drugs@FDA)
OMACOR
NDA · New Drug Application · Sponsor: RELIANT PHARMS · Approved 2007-06-12
Drug application
- FDA Application #
NDA021853
- Application type
- New Drug Application
- Brand name
- OMACOR
- Generic name
- Omega-3Acid Ethyl Esters
- Active ingredients
- OMEGA-3ACID ETHYL ESTERS
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- RELIANT PHARMS
- First approval
- 2007-06-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown