Treats acquired methemoglobinemia. ANDA 217561, held by Nexus. Methylene Blue.
As of Nov 15, 2026, ANDA 217561 (Methylene Blue), held by Nexus, was first approved by FDA on Nov 21, 2024, with 0 approved supplements and 0 published complete response letters.
Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methylene Blue50MG/10ML (5MG/ML) · solution;intravenous | Methylene Blue | 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
