FDA.reportPublic FDA data

Application 210531

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIMETHYL FUMARATEDIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORAL120MGNoNo
002DIMETHYL FUMARATEDIMETHYL FUMARATECAPSULE, DELAYED RELEASE;ORAL240MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0396Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0396Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0396Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0396Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0396Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0396Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0399Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0399Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0399Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0399Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0399Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent
0378-0399Dimethyl fumarateDimethyl fumarateMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64607ORIG2020-09-18