ANDA 76564, held by Teva Pharms USA. Adenosine.
As of Nov 13, 2026, ANDA 76564 (Adenosine), held by Teva Pharms USA, was first approved by FDA on Jun 16, 2004, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adenosine3MG/ML ยท injectable;injection | Adenosine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2010 | Supplement 4Labeling | Approved | None posted |
| Jun 16, 2004 | 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
