ANDA 211775, held by Alkem Labs Ltd. Cefixime.
As of Nov 13, 2026, ANDA 211775 (Cefixime), held by Alkem Labs Ltd, was first approved by FDA on Feb 19, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
