Janus-associated kinase (JAK) inhibitors
Tofacitinib
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- TOFACITINIB 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- TOFACITINIB 5MG · TabletANDA209923-001 · Tentative approval
- TOFACITINIB 10MG · TabletThis page
- TOFACITINIB 5MG · TabletANDA218437-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218437.
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
- Dosage form
- Tablet
- Applicant
- Annora Pharma Private Limited
- Status
- Tentative approval
- FDA approval
- 27 Dec 2024
- Application
- ANDA218437-001
- RxCUI
- 1357536