ANDA 213396, held by Fresenius Kabi USA. Daptomycin.
As of Nov 13, 2026, ANDA 213396 (Daptomycin), held by Fresenius Kabi USA, was first approved by FDA on Aug 1, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin350MG/VIAL · powder;intravenous | Daptomycin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 1, 2024 | 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
