# SOFDRA
> **NDA217347** · New Drug Application · Sponsor: BOTANIX SB · Approved 2024-06-18
## Drug
- **FDA Application Number:** NDA217347
- **Application type:** New Drug Application
- **Brand name:** SOFDRA
- **Generic name:** SOFPIRONIUM BROMIDE
- **Active ingredients:** SOFPIRONIUM BROMIDE
- **Dosage form:** GEL, METERED
- **Route:** TOPICAL
- **Marketing status:** Prescription
- **Sponsor:** BOTANIX SB
- **Manufacturer:** Botanix SB Inc.
- **First approval:** 2024-06-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217347)
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