FDA.reportPublic FDA data

Application 070597

Type
ANDA
Sponsor
HOSPIRA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9827Bupivacaine HydrochlorideBupivacaine HydrochlorideHenry Schein, IncANDACurrent
0404-9827Bupivacaine HydrochlorideBupivacaine HydrochlorideHenry Schein, IncANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-1163Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1396BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-163Bupivacaine HydrochlorideBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent