General MedicationsORALStandard
PALSONIFY
PALTUSOTINE HYDROCHLORIDE
Standard Dose
EQ 20MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PALSONIFY is listed in Drugs@FDA under application 219070 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PALTUSOTINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor CRINETICS Submission history Latest submission status date: 2025-09-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview PALSONIFY is listed in Drugs@FDA under application 219070 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PALTUSOTINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor CRINETICS Submission history Latest submission status date: 2025-09-25 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.