FDA.reportPublic FDA data

Application 204842

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%NoNo
002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo
003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.75%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9330Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9331Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9332Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9333Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9334Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9335Bupivacaine HydrochlorideBupivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent