# INTROVALE
> **ANDA079064** · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2010-09-27
## Drug
- **FDA Application Number:** ANDA079064
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** INTROVALE
- **Generic name:** LEVONORGESTREL AND ETHINYL ESTRADIOL
- **Active ingredients:** ETHINYL ESTRADIOL; LEVONORGESTREL
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** XIROMED
- **Manufacturer:** Xiromed, LLC.
- **First approval:** 2010-09-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=079064)
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