ANDA 209813, held by Teva Pharms USA. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 209813 (Tofacitinib Citrate), held by Teva Pharms USA, was first approved by FDA on Aug 17, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 17, 2026 | Original application | Approved | None posted |
| Tofacitinib CitrateEQ 11MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
| Tofacitinib CitrateEQ 22MG BASE · tablet, extended release;oral | Tofacitinib Citrate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
