FDA.reportPublic FDA data

Application 210189

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHYTONADIONEPHYTONADIONETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-973PhytonadionePhytonadioneNorthstar Rx LLC.ANDACurrent
16714-973PhytonadionePhytonadioneNorthstar Rx LLC.ANDACurrent
16714-973PhytonadionePhytonadioneNorthstar Rx LLC.ANDACurrent
60687-600PhytonadionePhytonadioneAmerican Health PackagingANDACurrent
70710-1014PhytonadionePhytonadioneZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1014PhytonadionePhytonadioneZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1014PhytonadionePhytonadioneZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1318PhytonadionePhytonadioneZydus Lifesciences LimitedANDACurrent
70771-1318PhytonadionePhytonadioneCadila Healthcare LimitedANDACurrent
70771-1318PhytonadionePhytonadioneCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68768ORIG2021-09-24