FDA.reportPublic FDA data

Application 210402

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
69238-1318Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1318Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1318Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1318Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1319Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1319Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1319Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1319Dimethyl FumarateDimethyl FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1626DIMETHYL FUMARATEDIMETHYL FUMARATEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1626DIMETHYL FUMARATEDIMETHYL FUMARATEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1626DIMETHYL FUMARATEDIMETHYL FUMARATEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1626DIMETHYL FUMARATEDIMETHYL FUMARATEAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55396ORIG2018-09-07