Composition
- Active ingredients
- PALTUSOTINE HYDROCHLORIDE EQ 30MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- PALTUSOTINE HYDROCHLORIDE EQ 20MG BASE · TabletNDA219070-001 · Prescription
- PALTUSOTINE HYDROCHLORIDE EQ 30MG BASE · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA219070.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Palsonify
- Active substance
- paltusotine hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Crinetics
- Status
- Prescription
- FDA approval
- 25 Sept 2025
- Application
- NDA219070-002