FDA
- Status: approved
🇺🇸 TOFACITINIB in United States
TOFACITINIB (TOFACITINIB) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA215552
- Marketing authorisation holder: YAOPHARMA CO LTD
- Local brand name: Tofacitinib
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA209633
- Marketing authorisation holder: BRECKENRIDGE PHARMS
- Local brand name: TOFACITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA217299
- Marketing authorisation holder: MSN PHARMS INC
- Local brand name: TOFACITINIB
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA219395
- Marketing authorisation holder: SPECGX LLC
- Local brand name: TOFACITINIB
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA215356
- Marketing authorisation holder: AUROBINDO PHARMA LIMITED
- Local brand name: TOFACITINIB
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA218437
- Marketing authorisation holder: ANNORA PHARMA PRIVATE LIMITED
- Local brand name: TOFACITINIB
- Indication: TABLET
- Status: approved
TOFACITINIB in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TOFACITINIB approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for TOFACITINIB in United States?
Marketing authorisation holder not available in our data.