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FDA Product

Methylene blue

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Methylene blue

70710-1837

Regulatory Information

70710-1837

ANDA215636

C73584

March 23, 2024

USA

These highlights do not include all the information needed to use METHYLENE BLUE INJECTION safely and effectively. See full prescribing information for METHYLENE BLUE INJECTION. METHYLENE BLUE Injection, USP for intravenous use Initial U.S. Approval: 2016

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

156861945

Active Ingredients

METHYLENE BLUE

Quantity: 5 mg in 1 mL

Code: T42P99266K

Class Code: ACTIB

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

METHYLENE BLUE CATION

Code: ZMZ79891ZH

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