FDA.reportPublic FDA data

Application 087955

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITAMIN K1PHYTONADIONEINJECTABLE;INJECTION10MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-9158Vitamin K1PHYTONADIONEHospira, Inc.ANDACurrent
0409-9158Vitamin K1PHYTONADIONEHospira, Inc.ANDACurrent
0409-9158Vitamin K1PHYTONADIONEHospira, Inc.ANDACurrent
0409-9158Vitamin K1PHYTONADIONEHospira, Inc.ANDACurrent
0409-9158Vitamin K1PHYTONADIONEHospira, Inc.ANDACurrent
0409-9158Vitamin K1PHYTONADIONEHospira, Inc.ANDACurrent
50090-4521Vitamin K1PHYTONADIONEA-S Medication SolutionsANDACurrent
50090-4521Vitamin K1PHYTONADIONEA-S Medication SolutionsANDACurrent
50090-4521Vitamin K1PHYTONADIONEA-S Medication SolutionsANDACurrent
51662-1536VITAMIN K1 - PHYTONADIONEVITAMIN K1 - PHYTONADIONEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1536VITAMIN K1 - PHYTONADIONEVITAMIN K1 - PHYTONADIONEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-158Vitamin K1PhytonadioneGeneral Injectables & Vaccines, IncANDACurrent
52584-158Vitamin K1PhytonadioneGeneral Injectables & Vaccines, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43206ORIG2005-07-22