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ACTIVE SUBSTANCE / INN

IMIQUIMOD

Brand name(s): IMIQUIMOD, ALDARA, Zyclara, Aldara, ZYCLARA, Zartra
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
ANDA091308
ANDA078837
ACTIVE SUBSTANCE
Imiquimod
REGULATORS
FDA · EMA
SPONSORS / MAH
PADAGIS ISRAEL, Laboratoires 3M Santé, BAUSCH
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
IMIQUIMODANDA078837PADAGIS ISRAELPrescription
IMIQUIMODANDA091308APOTEX INCDiscontinued
ALDARANDA020723BAUSCHDiscontinued
ZYCLARANDA022483BAUSCHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZyclaraViatris Healthcare LimitedAuthorised23/08/2012Keratosis;Keratosis, Actinic
AldaraViatris Healthcare LimitedAuthorised18/09/1998Condylomata Acuminata;Keratosis;Keratosis, Actinic;Carcinoma, Basal Cell
ZartraLaboratoires 3M SantéWithdrawn18/09/1998Condylomata Acuminata

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