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ACTIVE SUBSTANCE / INN

ROSIGLITAZONE MALEATE

Brand name(s): ROSIGLITAZONE MALEATE, AVANDARYL, AVANDAMET, ROSIGLITAZONE, ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE, ROSIGLITAZONE MALEATE AND GLIMEPIRIDE, AVANDIA
FDA LISTED
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA077337
ANDA078825
ACTIVE SUBSTANCE
Rosiglitazone Maleate
REGULATORS
FDA
SPONSORS / MAH
WATSON LABS, MYLAN PHARMA, TEVA
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEANDA077337TEVADiscontinued
ROSIGLITAZONE MALEATEANDA078825MYLAN PHARMANone (Tentative Approval)
AVANDIANDA021071WOODWARDDiscontinued
ROSIGLITAZONE MALEATE AND GLIMEPIRIDEANDA078709TEVA PHARMS USADiscontinued
ROSIGLITAZONEANDA078023WATSON LABSNone (Tentative Approval)
AVANDARYLNDA021700SB PHARMCODiscontinued
ROSIGLITAZONE MALEATEANDA076747ANI PHARMSDiscontinued
AVANDAMETNDA021410SB PHARMCODiscontinued

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