FDA.reportPublic FDA data

Application 071108

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLURAZEPAM HYDROCHLORIDEFLURAZEPAM HYDROCHLORIDECAPSULE;ORAL30MGNoNo
002FLURAZEPAM HYDROCHLORIDEFLURAZEPAM HYDROCHLORIDECAPSULE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-3370FlurazepamFlurazepam HydrochlorideWest-ward Pharmaceutical CorpANDACurrent
21695-363FlurazepamFlurazepam HydrochlorideRebel Distributors CorpANDACurrent
52959-236FlurazepamFlurazepam HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
68788-0408FlurazepamFlurazepam HydrochloridePreferred Pharmaceuticals, IncANDACurrent