ANDA 215215, held by Hangzhou Zhongmei. Daptomycin.
As of Nov 13, 2026, ANDA 215215 (Daptomycin), held by Hangzhou Zhongmei, was first approved by FDA on Nov 26, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daptomycin500MG/VIAL · powder;intravenous | Daptomycin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 26, 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
