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MYCAMINE (nda021506)- (EQ 50MG BASE/VIAL,EQ 100MG BASE/VIAL)

MICAFUNGIN SODIUM ASTELLAS
EQ 50MG BASE/VIAL,EQ 100MG BASE/VIAL
Yes No
2021-Jul-08 Expired
None None
None No
MYCAMINE® is an echinocandin indicated in adult and pediatric patients for:  Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.  Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.  Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.  Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
8 0 7
Total Other Developers None
Drugs with Suitability No
EQ 50MG BASE/VIAL ** ** - - -
EQ 100MG BASE/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 6
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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