FDA.reportPublic FDA data

Application 070690

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDESOLUTION;ORAL40MG/5MLNoYes
002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDESOLUTION;ORAL20MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3730Propranolol HydrochloridePropranolol HydrochlorideWest Ward Pharmaceuticals Corp.ANDACurrent
0054-3730Propranolol HydrochloridePropranolol HydrochlorideWest Ward Pharmaceuticals Corp.ANDACurrent