# SAFYRAL
> **NDA022574** · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2010-12-16
## Drug
- **FDA Application Number:** NDA022574
- **Application type:** New Drug Application
- **Brand name:** SAFYRAL
- **Generic name:** DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM
- **Active ingredients:** DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BAYER HLTHCARE
- **Manufacturer:** Bayer HealthCare Pharmaceuticals Inc.
- **First approval:** 2010-12-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022574)
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