ANDA 214349, held by Hospira. Regadenoson.
As of Nov 14, 2026, ANDA 214349 (Regadenoson), held by Hospira, was first approved by FDA on Aug 31, 2022, with 0 approved supplements and 0 published complete response letters.
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Regadenoson0.4MG/5ML (0.08MG/ML) · solution;intravenous | Regadenoson | 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
