Composition
- Active ingredients
- PITOLISANT 17.8MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218832.
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
- Pitolisant
- Dosage form
- Tablet
- Applicant
- Annora Pharma Private Limited
- Status
- Tentative approval
- FDA approval
- 2 Sept 2025
- Application
- ANDA218832-002