ANDA 205568, held by Fresenius Kabi USA. Adenosine.
As of Nov 13, 2026, ANDA 205568 (Adenosine), held by Fresenius Kabi USA, was first approved by FDA on Apr 16, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adenosine3MG/ML ยท injectable;injection | Adenosine | 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