FDA.reportPublic FDA data

Application 205141

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%NoNo
002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9328Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9329Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent