ANDA 208075, held by Apotex. Ceftaroline Fosamil.
As of Nov 15, 2026, ANDA 208075 (Ceftaroline Fosamil), held by Apotex, was first approved by FDA on Sep 21, 2021, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2021 | Original application | Approved |
| Ceftaroline Fosamil400MG/VIAL · powder;intravenous | Ceftaroline Fosamil | Rx |
| Ceftaroline Fosamil600MG/VIAL · powder;intravenous | Ceftaroline Fosamil | Rx |
| May 30, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 30, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 21, 2021 | Original application | Approved |
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
