FDA.reportPublic FDA data

Application 083722

Type
ANDA
Sponsor
INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHYTONADIONEPHYTONADIONEINJECTABLE;INJECTION1MG/0.5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9935PHYTONADIONEphytonadioneHenry Schein, Inc.ANDACurrent
0404-9935PHYTONADIONEphytonadioneHenry Schein, Inc.ANDACurrent
52584-043PHYTONADIONEphytonadioneGeneral Injectables & Vaccines, IncANDACurrent
52584-046PHYTONADIONEphytonadioneGeneral Injectables & Vaccines, IncANDACurrent
52584-046PHYTONADIONEphytonadioneGeneral Injectables & Vaccines, IncANDACurrent
52584-046PHYTONADIONEphytonadioneGeneral Injectables & Vaccines, IncANDACurrent
52584-240PhytonadionePhytonadioneGeneral Injectables & Vaccines, IncANDACurrent
76329-1240PhytonadionePhytonadioneInternational Medication Systems, LimitedANDACurrent
76329-1240PhytonadionePhytonadioneInternational Medication Systems, LimitedANDACurrent
76329-1240PhytonadionePhytonadioneInternational Medication Systems, LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76936SUPPL 2023-12-18
76935SUPPL 2023-12-18
76934SUPPL 2023-12-18
76933SUPPL 2023-12-18
76932SUPPL 2023-12-18
76931SUPPL 2023-12-18
68759SUPPL2021-09-24
68758SUPPL2021-09-24