General MedicationsORALGeneric
TOFACITINIB CITRATE
TOFACITINIB CITRATE
Standard Dose
22MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview TOFACITINIB CITRATE is listed in Drugs@FDA under application 218668 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient TOFACITINIB CITRATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 22MG Sponsor DEXCEL Submission history Latest submission status date: 2024-12-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview TOFACITINIB CITRATE is listed in Drugs@FDA under application 218668 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient TOFACITINIB CITRATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 22MG Sponsor DEXCEL Submission history Latest submission status date: 2024-12-16 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.