Composition
- Active ingredients
- IVACAFTOR 150MG
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 ANDA216074.
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
- Ivacaftor
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Lupin LTD
- Status
- Tentative approval
- FDA approval
- 7 Jun 2022
- Application
- ANDA216074-001