Treats acquired methemoglobinemia. ANDA 216959, held by Hikma. Methylene Blue.
As of Nov 15, 2026, ANDA 216959 (Methylene Blue), held by Hikma, was first approved by FDA on Dec 17, 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 |
|---|---|---|---|
| Dec 17, 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
