FDA.reportPublic FDA data

Application 065410

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILCAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0163Mycophenolate MofetilMycophenolate MofetilHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
0054-0163Mycophenolate MofetilMycophenolate MofetilWest-Ward Pharmaceuticals CorpANDACurrent
60687-494Mycophenolate MofetilMycophenolate MofetilAmerican Health PackagingANDACurrent
60687-494Mycophenolate MofetilMycophenolate MofetilAmerican Health PackagingANDACurrent
60687-494Mycophenolate MofetilMycophenolate MofetilAmerican Health PackagingANDACurrent
69189-0164Mycophenolate MofetilMycophenolate MofetilAvera McKennan HospitalANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44523ORIG2015-07-02
39424ORIG2008-11-20
44237ORIG2008-09-19
8398ORIG2008-08-01