FDA.reportPublic FDA data

Application 090194

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION20MG/10ML (2MG/ML)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/20ML (7.5MG/ML)NoNo
004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION100MG/10ML (10MG/ML)NoNo
005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION40MG/20ML (2MG/ML)NoNo
006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/20ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent