ANDA 213236, held by Accord Hlthcare. Regadenoson.
As of Nov 14, 2026, ANDA 213236 (Regadenoson), held by Accord Hlthcare, was first approved by FDA on Apr 11, 2022, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Regadenoson0.4MG/5ML (0.08MG/ML) · solution;intravenous | Regadenoson | Rx |
| Feb 8, 2024 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 2, 2022 | Supplement 2Manufacturing | Approved | None posted |
| Apr 11, 2022 | 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
