FDA.reportPublic FDA data

Application 072755

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORAZEPAM INTENSOLLORAZEPAMCONCENTRATE;ORAL2MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3532LorazepamLorazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3532LorazepamLorazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3532LorazepamLorazepamWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-3532LorazepamLorazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3532LorazepamLorazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3532LorazepamLorazepamATLANTIC BIOLOGICALS CORP.ANDACurrent