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ACTIVE SUBSTANCE / INN

AZELAIC ACID

Brand name(s): FINACEA, AZELAIC ACID, AZELEX
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA210549
NDA021470
ACTIVE SUBSTANCE
Azelaic Acid
REGULATORS
FDA
SPONSORS / MAH
TARO PHARM INDS LTD, LEO PHARMA AS, ALMIRALL
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AZELAIC ACIDANDA210928AUROBINDO PHARMA USADiscontinued
AZELAIC ACIDANDA210549SUN PHARMA CANADAPrescription
AZELAIC ACIDANDA212581TARO PHARM INDS LTDNone (Tentative Approval)
FINACEANDA021470LEO PHARMA ASPrescription
AZELEXNDA020428ALMIRALLPrescription

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