FDA.reportPublic FDA data

Application 077699

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEFLOQUINE HYDROCHLORIDEMEFLOQUINE HYDROCHLORIDETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1282Mefloquine HydrochlorideMefloquine HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
21695-561Mefloquine HydrochlorideMefloquine HydrochlorideRebel Distributors CorpANDACurrent
52959-803Mefloquine HydrochlorideMefloquine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent