FDA.reportPublic FDA data

Application 076246

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLEFOR SUSPENSION;ORAL50MG/5MLNoNo
002FLUCONAZOLEFLUCONAZOLEFOR SUSPENSION;ORAL200MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0002FluconazoleFluconazoleHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0002FluconazoleFluconazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0002FluconazoleFluconazoleWest-Ward PharmaceuticalsANDACurrent
0054-0002FluconazoleFluconazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0003FluconazoleFluconazoleHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0003FluconazoleFluconazoleWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0003FluconazoleFluconazoleWest-Ward PharmaceuticalsANDACurrent
0054-0003FluconazoleFluconazoleWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8881ORIG2004-07-30