FDA.reportPublic FDA data

Application 214074

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION40MG/20ML (2MG/ML)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/20ML (7.5MG/ML)NoNo
004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/20ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9263Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9263Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9264Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9264Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9265Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9265Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9266Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9266Ropivacaine HydrochlorideRopivacaine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent