# MIRENA
> **NDA021225** · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2000-12-06
## Drug
- **FDA Application Number:** NDA021225
- **Application type:** New Drug Application
- **Brand name:** MIRENA
- **Generic name:** LEVONORGESTREL
- **Active ingredients:** LEVONORGESTREL
- **Dosage form:** SYSTEM
- **Route:** INTRAUTERINE
- **Marketing status:** Prescription
- **Sponsor:** BAYER HLTHCARE
- **Manufacturer:** Bayer HealthCare Pharmaceuticals Inc.
- **First approval:** 2000-12-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021225)
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