# SIRTURO
> **NDA204384** · New Drug Application · Sponsor: JANSSEN THERAP · Approved 2012-12-28
## Drug
- **FDA Application Number:** NDA204384
- **Application type:** New Drug Application
- **Brand name:** SIRTURO
- **Generic name:** BEDAQUILINE FUMARATE
- **Active ingredients:** BEDAQUILINE FUMARATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** JANSSEN THERAP
- **Manufacturer:** Janssen Products, LP
- **First approval:** 2012-12-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204384)
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