FDA.reportPublic FDA data

Application 208306

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-380Methadone HydrochlorideMethadone HydrochlorideAkornANDACurrent
17478-380Methadone HydrochlorideMethadone HydrochlorideAkornANDACurrent
17478-380Methadone HydrochlorideMethadone HydrochlorideAkornANDACurrent
17478-380Methadone HydrochlorideMethadone HydrochlorideAkorn, Inc.ANDACurrent
17478-380Methadone HydrochlorideMethadone HydrochlorideAkorn, Inc.ANDACurrent
17478-380Methadone HydrochlorideMethadone HydrochlorideAkorn, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50343ORIG2017-11-08