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ACTIVE SUBSTANCE / INN

BUDESONIDE

Brand name(s): Jorveza, BUDESONIDE, AIRSUPRA, SYMBICORT, ENTOCORT EC, Kinpeygo, BREYNA, UCERIS, SYMBICORT AEROSPHERE, BREZTRI AEROSPHERE
FDA LISTED
EMA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
ANDA078949
Glomerulonephritis, IGA
ACTIVE SUBSTANCE
Budesonide
REGULATORS
FDA · EMA
SPONSORS / MAH
SANDOZ, Dr. Falk Pharma GmbH, ASTRAZENECA AB
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BUDESONIDEANDA206200AMNEAL PHARMSPrescription
BREYNAANDA211699MYLANPrescription
AIRSUPRANDA214070ASTRAZENECAPrescription
BUDESONIDEANDA078949APOTEXOver-the-counter
BUDESONIDEANDA201966SANDOZDiscontinued
BREZTRI AEROSPHERENDA212122ASTRAZENECA ABPrescription
SYMBICORT AEROSPHERENDA216579ASTRAZENECAPrescription
ENTOCORT ECNDA021324PADAGIS USPrescription
SYMBICORTNDA021929ASTRAZENECAPrescription
UCERISNDA205613SALIXPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KinpeygoStada Arzneimittel AGAuthorised15/07/2022Glomerulonephritis, IGA
JorvezaDr. Falk Pharma GmbHAuthorised08/01/2018Esophageal Diseases

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