# KYLEENA
> **NDA208224** · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2016-09-16
## Drug
- **FDA Application Number:** NDA208224
- **Application type:** New Drug Application
- **Brand name:** KYLEENA
- **Generic name:** LEVONORGESTREL
- **Active ingredients:** LEVONORGESTREL
- **Dosage form:** SYSTEM
- **Route:** INTRAUTERINE
- **Marketing status:** Prescription
- **Sponsor:** BAYER HLTHCARE
- **Manufacturer:** Bayer HealthCare Pharmaceuticals Inc.
- **First approval:** 2016-09-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208224)
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