FDA.reportPublic FDA data

Application 089897

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDE INTENSOLMETHADONE HYDROCHLORIDECONCENTRATE;ORAL10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0391Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0391Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0391Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0391Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USAANDACurrent
0054-0391Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3553Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3553Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-3553Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
70166-284Methadone HydrochlorideMethadone HydrochlorideLohxaANDACurrent
70166-284Methadone HydrochlorideMethadone HydrochlorideLohxaANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44544ORIG2015-06-30
18532SUPPL2014-05-06
44413ORIG2006-11-27