Treats acquired methemoglobinemia. ANDA 216955, held by Steriscience. Methylene Blue.
As of Nov 15, 2026, ANDA 216955 (Methylene Blue), held by Steriscience, was first approved by FDA on Nov 22, 2024, with 0 approved supplements and 0 published complete response letters.
Methylene blue injection, USP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 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
