FDA.reportPublic FDA data

Application 200068

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINEZOLIDLINEZOLIDFOR SUSPENSION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0319LinezolidlinezolidWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0319LinezolidlinezolidWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0319LinezolidlinezolidHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0319LinezolidlinezolidHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0319LinezolidlinezolidWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32007ORIG2015-06-04
32006ORIG2013-12-05