copper histidinate

FDA Drug Profile — Zycubo

Drug Details

Generic Name
copper histidinate
Brand Names
Zycubo
Application Number
NDA211241
Sponsor
Sentynl Therapeutics, Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
COPPER HISTIDINATE

Indications and Usage

1 INDICATIONS AND USAGE ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.