ANDA 210725, held by Apotex. Afatinib Dimaleate.
As of Nov 15, 2026, ANDA 210725 (Afatinib Dimaleate), held by Apotex, was first approved by FDA on Jul 14, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 2026 | Original application | Approved | None posted |
| Afatinib DimaleateEQ 20MG BASE · tablet;oral | Afatinib Dimaleate | Rx |
| Afatinib DimaleateEQ 30MG BASE · tablet;oral | Afatinib Dimaleate | Rx |
| Afatinib DimaleateEQ 40MG BASE · tablet;oral | Afatinib Dimaleate | 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
