FDA.reportPublic FDA data

Application 088744

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDESYRUP;ORAL50MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76205ORIG 2023-11-03