FDA.reportPublic FDA data

Application 203118

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUTASTERIDEDUTASTERIDECAPSULE;ORAL0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3040DutasterideDutasterideA-S Medication SolutionsANDACurrent
65162-750DutasterideDutasterideAmneal Pharmaceuticals LLCANDACurrent
65162-750DutasterideDutasterideAmneal Pharmaceuticals LLCANDACurrent
65162-750DutasterideDutasterideAmneal Pharmaceuticals LLCANDACurrent
65162-750DutasterideDutasterideAmneal Pharmaceuticals LLCANDACurrent
68071-4607DutasterideDutasterideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1966DutasterideDutasterideREMEDYREPACK INC.ANDACurrent
71205-039DutasterideDutasterideProficient Rx LPANDACurrent
71205-039DutasterideDutasterideProficient Rx LPANDACurrent