# EPOPROSTENOL SODIUM
> **ANDA219237** · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2025-12-29
## Drug
- **FDA Application Number:** ANDA219237
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** EPOPROSTENOL SODIUM
- **Generic name:** EPOPROSTENOL
- **Active ingredients:** EPOPROSTENOL SODIUM
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** GLAND
- **Manufacturer:** Gland Pharma Limited
- **First approval:** 2025-12-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219237)
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