FDA.reportPublic FDA data

Application 075853

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEINJECTABLE;INJECTION100MG/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4350Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4350Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4350Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4350Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4350Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1457DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1457DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1457DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent