FDA.reportPublic FDA data

Application 078601

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEINJECTABLE; INJECTION5MG/ML(0.5%)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/20ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3140Ropivacaine HydrochlorideRopivacaine HydrochlorideSandoz IncANDACurrent
0781-3142Ropivacaine HydrochlorideRopivacaine HydrochlorideSandoz IncANDACurrent