Treats acquired methemoglobinemia. ANDA 217380, held by Meitheal. Methylene Blue.
As of Nov 15, 2026, ANDA 217380 (Methylene Blue), held by Meitheal, was first approved by FDA on Jan 23, 2025, 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 |
|---|---|---|---|
| Jan 23, 2025 | 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
