Janus-associated kinase (JAK) inhibitors
Tofacitinib
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- TOFACITINIB 5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- TOFACITINIB 5MG · TabletThis page
- TOFACITINIB 10MG · TabletANDA218437-001 · Tentative approval
- TOFACITINIB 5MG · TabletANDA218437-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA209923.
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
- Tofacitinib
- Drug class
- Janus-associated kinase (JAK) inhibitors
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Prinston Pharma Inc
- Status
- Tentative approval
- FDA approval
- 9 Apr 2024
- Application
- ANDA209923-001
- RxCUI
- 1357536