FDA.reportPublic FDA data

Application 010104

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003MEPHYTONPHYTONADIONETABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-1704MephytonphytonadioneValeant Pharmaceuticals North America LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health Americas, Inc.NDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
0187-1704MephytonphytonadioneBausch Health US LLCNDACurrent
21695-168MEPHYTONphytonadioneRebel Distributors CorpNDACurrent
50090-1753MephytonphytonadioneA-S Medication SolutionsNDACurrent
50090-1753MephytonphytonadioneA-S Medication SolutionsNDACurrent
50090-1753MephytonphytonadioneA-S Medication SolutionsNDACurrent
50268-661PhytonadionephytonadioneAvPAKNDA AUTHORIZED GENERICCurrent
68151-0158MephytonphytonadioneCarilion Materials ManagementNDACurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-170PhytonadionephytonadioneOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83117SUPPL 2025-08-18
68128SUPPL2021-07-20
68125SUPPL2021-07-20
52765ORIG2018-02-28
10736SUPPL2012-11-27
11889SUPPL2010-01-26
11888SUPPL2004-03-02