FDA.reportPublic FDA data

Application 087393

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3555Methadone HydrochlorideMethadone HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-3555Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3555Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
68094-031Methadone HydrochlorideMethadone HydrochloridePrecision Dose, Inc.ANDACurrent
68094-031Methadone HydrochlorideMethadone HydrochloridePrecision Dose, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44543ORIG2015-06-30
39594SUPPL2014-05-06