← FDA Drug Approvals (Drugs@FDA)

METHYLENE BLUE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2025-07-30

Drug application

FDA Application #

ANDA219363

Application type

Abbreviated New Drug Application (Generic)

Brand name

METHYLENE BLUE

Generic name

METHYLENE BLUE

Active ingredients

METHYLENE BLUE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

XIROMED

Manufacturer

XIROMED, LLC

First approval

2025-07-30

Source

Authoritative

Drugs@FDA application overview

Machine

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