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ACTIVE SUBSTANCE / INN

HYDROCORTISONE

Brand name(s): Efmody, OTICAIR, HYTONE, PYOCIDIN, HYDROCORTISONE, NUTRACORT, CETACORT, Alkindi, CORTENEMA, GLYCORT, Plenadren, NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Adrenal Hyperplasia, Congenital
ANDA080395
ACTIVE SUBSTANCE
Hydrocortisone
REGULATORS
FDA · EMA
SPONSORS / MAH
DOW PHARM, BAUSCH AND LOMB, SANDOZ
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
HYDROCORTISONEANDA080395PUREPAC PHARMDiscontinued
HYTONEANDA080474DERMIK LABSDiscontinued
GLYCORTANDA087489HERANDiscontinued
NUTRACORTANDA087644DOW PHARMDiscontinued
HYDROCORTISONEANDA088799TAROPrescription
PYOCIDINANDA061606FOREST LABSDiscontinued
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEANDA062874SANDOZPrescription
OTICAIRANDA064065BAUSCH AND LOMBPrescription
CORTENEMANDA016199ANI PHARMSPrescription
CETACORTANDA080426BAUSCHDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AlkindiImmedica Netherlands B.V.Authorised09/02/2018Adrenal Insufficiency
EfmodyImmedica Netherlands B.V.Authorised27/05/2021Adrenal Hyperplasia, Congenital
PlenadrenTakeda Pharmaceuticals International AG Ireland BranchAuthorised03/11/2011Adrenal Insufficiency

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