# BALCOLTRA
> **NDA208612** · New Drug Application · Sponsor: AVION PHARMS · Approved 2018-01-09
## Drug
- **FDA Application Number:** NDA208612
- **Application type:** New Drug Application
- **Brand name:** BALCOLTRA
- **Generic name:** LEVONORGESTREL AND ETHINYL ESTRADIOL
- **Active ingredients:** ETHINYL ESTRADIOL; LEVONORGESTREL
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AVION PHARMS
- **Manufacturer:** Avion Pharmaceuticals
- **First approval:** 2018-01-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208612)
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