FDA.reportPublic FDA data

Application 040180

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0392Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0392Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0392Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0392Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USAANDACurrent
0054-0392Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
17856-0392Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0392Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0392Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0392Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
68094-032Methadone HydrochlorideMethadone HydrochloridePrecision Dose, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7575ORIG1998-04-30