MedPath
FDA Product

PEDMARK

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

Basic Information

PEDMARK

73077-010

Regulatory Information

73077-010

NDA212937

C73594

September 30, 2022

USA

These highlights do not include all the information needed to use PEDMARK safely and effectively. See full prescribing information for PEDMARK. PEDMARK (sodium thiosulfate injection), for intravenous use Initial U.S. Approval: 1992

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

159861132

Active Ingredients

BORIC ACID

Code: R57ZHV85D4

Class Code: IACT

SODIUM THIOSULFATE

Quantity: 12.5 g in 100 mL

Code: HX1032V43M

Class Code: ACTIM

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

THIOSULFATE ION

Code: LLT6XV39PY

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