FDA.reportPublic FDA data

Application 070928

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIAZEPAMDIAZEPAMSOLUTION;ORAL5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3188DiazepamDiazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3188DiazepamDiazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3188DiazepamDiazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3188DiazepamDiazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3188DiazepamDiazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0121-0905DiazepamDiazepamPharmaceutical Associates, Inc.ANDACurrent
0121-0905DiazepamDiazepamPharmaceutical Associates, Inc.ANDACurrent
0904-7117DiazepamDiazepamMajor PharmaceuticalsANDACurrent
17856-3188DiazepamDiazepamAtlantic Biologicals CorpsANDACurrent
17856-3188DiazepamDiazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3188DiazepamDiazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3188DiazepamDiazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
68094-750DiazepamDiazepamPrecision Dose Inc.ANDACurrent
68094-750DiazepamDiazepamPrecision Dose Inc.ANDACurrent
68094-750DiazepamDiazepamPrecision Dose Inc.ANDACurrent
68094-750DiazepamDiazepamPrecision Dose Inc.ANDACurrent
68094-750DiazepamDiazepamPrecision Dose Inc.ANDACurrent