← FDA Drug Approvals (Drugs@FDA)
IBSRELA
NDA · New Drug Application · Sponsor: ARDELYX INC · Approved 2019-09-12
Drug application
- FDA Application #
NDA211801- Application type
- New Drug Application
- Brand name
- IBSRELA
- Generic name
- TENAPANOR HYDROCHLORIDE
- Active ingredients
- TENAPANOR HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ARDELYX INC
- Manufacturer
- Ardelyx, Inc.
- First approval
- 2019-09-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown