ANDA 219002, held by Hikma. Trametinib Dimethyl Sulfoxide.
As of Nov 15, 2026, ANDA 219002 (Trametinib Dimethyl Sulfoxide), held by Hikma, was first approved by FDA on Aug 6, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2024 | Original application | Approved | None posted |
| Trametinib Dimethyl SulfoxideEQ 0.5MG · tablet;oral | Trametinib Dimethyl Sulfoxide | Discontinued |
| Trametinib Dimethyl SulfoxideEQ 2MG · tablet;oral | Trametinib Dimethyl Sulfoxide | Discontinued |
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
