ANDA 77897, held by Fresenius Kabi USA. Adenosine.
As of Nov 14, 2026, ANDA 77897 (Adenosine), held by Fresenius Kabi USA, was first approved by FDA on Nov 27, 2017, with 0 approved supplements and 0 published complete response letters.
Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2017 | Original application | Approved | None posted |
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
