FDA.reportPublic FDA data

Application 209373

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6882PhytonadionePhytonadioneMajor PharmaceuticalsANDACurrent
0904-6882PhytonadionePhytonadioneMajor PharmaceuticalsANDACurrent
0904-6882PhytonadionePhytonadioneMajor PharmaceuticalsANDACurrent
60687-381PhytonadionePhytonadioneAmerican Health PackagingANDACurrent
60687-381PhytonadionePhytonadioneAmerican Health PackagingANDACurrent
60687-381PhytonadionePhytonadioneAmerican Health PackagingANDACurrent
69238-1051PhytonadionePhytonadioneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1051PhytonadionePhytonadioneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1051PhytonadionePhytonadioneAmneal Pharmaceuticals LLCANDACurrent
69238-1051PhytonadionePhytonadioneAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54450ORIG2018-06-05