FDA.reportPublic FDA data

Application 070434

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FUROSEMIDEFUROSEMIDESOLUTION;ORAL10MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3294FurosemideFurosemideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3294FurosemideFurosemideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3294FurosemideFurosemideWest-Ward Pharmaceuticals Corp.ANDACurrent
68094-756FurosemideFurosemidePrecision Dose Inc.ANDACurrent
68094-756FurosemideFurosemidePrecision Dose Inc.ANDACurrent
68094-756FurosemideFurosemidePrecision Dose Inc.ANDACurrent
68094-756FurosemideFurosemidePrecision Dose Inc.ANDACurrent
68094-756FurosemideFurosemidePrecision Dose Inc.ANDACurrent
68094-756FurosemideFurosemidePrecision Dose Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18340SUPPL2013-09-06