FDA.reportPublic FDA data

Application 077090

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEFLUNOMIDELEFLUNOMIDETABLET;ORAL10MGNoNo
002LEFLUNOMIDELEFLUNOMIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-420LEFLUNOMIDELEFLUNOMIDEAvKARE, IncANDACurrent
42291-420LEFLUNOMIDELEFLUNOMIDEAvKAREANDACurrent
42291-420LEFLUNOMIDELEFLUNOMIDEAvKAREANDACurrent
42291-421LEFLUNOMIDELEFLUNOMIDEAvKARE, IncANDACurrent
42291-421LEFLUNOMIDELEFLUNOMIDEAvKAREANDACurrent
42291-421LEFLUNOMIDELEFLUNOMIDEAvKAREANDACurrent
50268-477LEFLUNOMIDELEFLUNOMIDEAvPAKANDACurrent
50268-477LEFLUNOMIDELEFLUNOMIDEAvPAKANDACurrent
50268-478LEFLUNOMIDELEFLUNOMIDEAvPAKANDACurrent
50268-478LEFLUNOMIDELEFLUNOMIDEAvPAKANDACurrent
60505-2502LEFLUNOMIDELEFLUNOMIDEApotex Corp.ANDACurrent
60505-2503LEFLUNOMIDELEFLUNOMIDEApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44341ORIG2010-08-09
9003ORIG2005-09-15