# RAYALDEE
> **NDA208010** · New Drug Application · Sponsor: EIRGEN · Approved 2016-06-17
## Drug
- **FDA Application Number:** NDA208010
- **Application type:** New Drug Application
- **Brand name:** RAYALDEE
- **Generic name:** CALCIFEDIOL
- **Active ingredients:** CALCIFEDIOL
- **Dosage form:** CAPSULE, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** EIRGEN
- **Manufacturer:** OPKO Pharmaceuticals LLC
- **First approval:** 2016-06-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208010)
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*MORVS · CC0 1.0*