DOCEFREZ (docetaxel) NDA 022534

by SUN PHARMA GLOBAL

attributevalue
Drug NameDOCEFREZ
Application Number022534
Active Ingredient(s)DOCETAXEL
CompanySUN PHARMA GLOBAL
Dosages/Routes/Forms
Drug NameActive Ingredient(s)StrengthForm/RouteMarketing StatusRLDTE Code
DOCEFREZDOCETAXEL20MG/VIALINJECTABLE; INJECTION11
DOCEFREZDOCETAXEL80MG/VIALINJECTABLE; INJECTION11
Approval History
DateSupplement No.ActionDocuments
Jul 20, 2012002Labeling Revision
Feb 23, 2010000Tentative Approval