FDA.reportPublic FDA data

Application 065413

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0166Mycophenolate MofetilMycophenolate MofetilHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0166Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24041ORIG2015-07-06
39425ORIG2008-11-20
44238ORIG2008-09-19
8399ORIG2008-08-04