APPLICATION
ANDA215636
TYPE
ANDA
ORIGINAL APPROVAL
2023-12-05
LATEST ACTION
2026-03-31
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METHYLENE BLUEPrescription
METHYLENE BLUE 5MG/ML (5MG/ML) · SOLUTION · INTRAVENOUS
METHYLENE BLUEPrescription
METHYLENE BLUE 10MG/2ML (5MG/ML) · SOLUTION · INTRAVENOUS
METHYLENE BLUEPrescription
METHYLENE BLUE 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS
METHYLENE BLUEPrescription
METHYLENE BLUE 50MG/10ML (5MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2026-03-31Manufacturing (CMC) · Supplement 6 · unknownAP
2026-02-02Manufacturing (CMC) · Supplement 4 · unknownAP
2025-03-04Labeling · Supplement 5 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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