# PYLERA
> **NDA050786** · New Drug Application · Sponsor: LABS JUVISE · Approved 2006-09-28
## Drug
- **FDA Application Number:** NDA050786
- **Application type:** New Drug Application
- **Brand name:** PYLERA
- **Generic name:** BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
- **Active ingredients:** BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** LABS JUVISE
- **Manufacturer:** H2-Pharma, LLC
- **First approval:** 2006-09-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050786)
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