# PROGESTERONE
> **ANDA218391** · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2025-09-19
## Drug
- **FDA Application Number:** ANDA218391
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROGESTERONE
- **Generic name:** PROGESTERONE
- **Active ingredients:** PROGESTERONE
- **Dosage form:** INSERT
- **Route:** VAGINAL
- **Marketing status:** Prescription
- **Sponsor:** XIROMED
- **Manufacturer:** XIROMED, LLC
- **First approval:** 2025-09-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218391)
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