ANDA 219395, held by Specgx LLC. Tofacitinib Citrate.
As of Nov 15, 2026, ANDA 219395 (Tofacitinib Citrate), held by Specgx LLC, was first approved by FDA on Jun 3, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2026 | Original application | Approved | None posted |
| Tofacitinib CitrateEQ 5MG BASE · tablet;oral | Tofacitinib Citrate | Rx |
| Tofacitinib CitrateEQ 10MG BASE · tablet;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
