FDA.reportPublic FDA data

Application 087997

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESOLUTION;ORAL10MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3556Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3556Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3556Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3556Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3556Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3556Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3556Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-3556Methadone HydrochlorideMethadone HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-3556Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3556Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24066ORIG2015-06-30
39597SUPPL2014-08-05