Methylene Blue

Treats acquired methemoglobinemia. Sold as Provayblue. Every FDA application for this active ingredient: 1 branded and 7 generic.

As of Nov 15, 2026, FDA lists 8 applications for Methylene Blue (sold as Provayblue), first approved Apr 8, 2016, with 1 new use approved and 0 published complete response letters.

First approved: Apr 8, 2016
Applications: 8
New uses approved: 1
Complete response letters: 0

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of methemoglobinemiaFera Pharmaceuticals, LLC · designated Jul 24, 2012

Clinical Trials

72 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical PeriodontitisApical Periodontitis, Endodontic Retreatment · Karadeniz Technical University	Not applicable	Recruiting	Nov 6, 2026
Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal DissectionGastric Neoplasms, Gastric Dysplasia · Unidade Local de Saúde do Alto Ave, EPE	Not applicable	Recruiting	Nov 5, 2026
Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal SurgeryColorectal Cancer, Colorectal Surgery · Chinese University of Hong Kong	Phase 4	Not yet recruiting	Oct 6, 2026
Real-time Fluorescence Microscopy for Intraoperative Assessment of Prostate Biopsy Cores (FLASH)Prostate Cancer (Diagnosis), Prostatic Neoplasms · Shanghai East Hospital	—	Not yet recruiting	Sep 29, 2026
Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided Colorectal SurgeryColorectal Surgery, Ureter · Chinese University of Hong Kong	Phase 4	Not yet recruiting	Sep 23, 2026
Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma After Low Anterior Resection for Rectal CancerRectal Cancers · Peking University Cancer Hospital & Institute	Phase 2	Recruiting	Sep 22, 2026
Clinical, Dermoscopic, and Mycological Evaluations of Resistant DermatophytosisFungal Skin Infection, Tinea Corporis · Sohag University	—	Not yet recruiting	Sep 1, 2026
ENLIGHT Trial: ESG With Fundal Mucosal AblationObesity, Obesity (Body Mass Index >30 kg/m2) · West Virginia University	Not applicable	Recruiting	Aug 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 8, 2016	ProvayblueNDA 204630 · New formulation or manufacturer	Provepharm Sas	12	Marketed
Dec 5, 2023	Methylene BlueANDA 215636	Zydus Lifesciences	3	Marketed
Nov 21, 2024	Methylene BlueANDA 217561	Nexus	0	Marketed
Nov 22, 2024	Methylene BlueANDA 216955	Steriscience	0	Marketed
Dec 17, 2024	Methylene BlueANDA 216959	Hikma	0	Marketed
Jan 23, 2025	Methylene BlueANDA 217380	Meitheal	0	Marketed
Jul 30, 2025	Methylene BlueANDA 219363	Xiromed	0	Marketed
Dec 23, 2025	Methylene BlueANDA 219550	Chengdu Shuode	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA