FDA.reportPublic FDA data

Application 215106

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL4MGNoNo
002DEXAMETHASONEDEXAMETHASONETABLET;ORAL6MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7266dexamethasonedexamethasoneMajor PharmaceuticalsANDACurrent
60219-2043dexamethasonedexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-2043dexamethasonedexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-2044dexamethasonedexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
60219-2044dexamethasonedexamethasoneAmneal Pharmaceuticals NY LLCANDACurrent
68071-2744dexamethasonedexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8223dexamethasonedexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
68788-8293dexamethasonedexamethasonePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69693ORIG2021-12-20