FDA.reportPublic FDA data

Application 210619

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43986-008Trientine HydrochlorideTrientine HydrochlorideBluepharma - Industria Farmaceutica, S.A.ANDACurrent
43986-008Trientine HydrochlorideTrientine HydrochlorideBluepharma - Industria Farmaceutica, S.A.ANDACurrent
43986-008Trientine HydrochlorideTrientine HydrochlorideBluepharma - Industria Farmaceutica, S.A.ANDACurrent
69238-1545Trientine HydrochlorideTrientineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1545Trientine HydrochlorideTrientineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1545Trientine HydrochlorideTrientineAmneal Pharmaceuticals LLCANDACurrent