# OPCICON ONE-STEP
> **ANDA202635** · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2014-09-11
## Drug
- **FDA Application Number:** ANDA202635
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** OPCICON ONE-STEP
- **Generic name:** LEVONORGESTREL
- **Active ingredients:** LEVONORGESTREL
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** SUN PHARM
- **Manufacturer:** Cardinal Health 110, LLC. DBA Leader
- **First approval:** 2014-09-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202635)
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