← FDA Drug Approvals (Drugs@FDA)
PYLERA
NDA · New Drug Application · Sponsor: LABS JUVISE · Approved 2006-09-28
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown