# OMEGA-3-ACID ETHYL ESTERS
> **ANDA211355** · Abbreviated New Drug Application (Generic) · Sponsor: SOFGEN PHARMS · Approved 2019-07-10
## Drug
- **FDA Application Number:** ANDA211355
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** OMEGA-3-ACID ETHYL ESTERS
- **Generic name:** OMEGA-3-ACID ETHYL ESTERS
- **Active ingredients:** OMEGA-3-ACID ETHYL ESTERS
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SOFGEN PHARMS
- **Manufacturer:** Chartwell RX, LLC
- **First approval:** 2019-07-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211355)
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