← FDA Drug Approvals (Drugs@FDA)
PALSONIFY
NDA · New Drug Application · Sponsor: CRINETICS · Approved 2025-09-25
Drug application
- FDA Application #
NDA219070- Application type
- New Drug Application
- Brand name
- PALSONIFY
- Generic name
- PALTUSOTINE
- Active ingredients
- PALTUSOTINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- CRINETICS
- Manufacturer
- Crinetics Pharmaceuticals, Inc.
- First approval
- 2025-09-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown