Methylene Blue

Treats acquired methemoglobinemia. ANDA 215636, held by Zydus Lifesciences. Methylene Blue.

As of Nov 15, 2026, ANDA 215636 (Methylene Blue), held by Zydus Lifesciences, was first approved by FDA on Dec 5, 2023, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 5, 2023
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 5, 2023	Original application	Approved	Letter

Products

4 strengths and forms


Methylene Blue10MG/2ML (5MG/ML) · solution;intravenous	Methylene Blue	Rx
Methylene Blue50MG/10ML (5MG/ML) · solution;intravenous	Methylene Blue	Rx
Methylene Blue5MG/ML (5MG/ML) · solution;intravenous	Methylene Blue	Rx
Methylene Blue100MG/10ML (10MG/ML) · solution;intravenous	Methylene Blue	Rx

All 4 submissions, including labeling and manufacturing supplements


Mar 31, 2026	Supplement 6Manufacturing	Approved	None posted
Feb 2, 2026	Supplement 4Manufacturing	Approved	None posted
Mar 4, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Dec 5, 2023	Original application	Approved	Letter

Identifiers

Application: ANDA 215636
Drugs@FDA: Overview at FDA
Company: Zydus Lifesciences

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