FDA.reportPublic FDA data

Application 210460

Type
ANDA
Sponsor
MSN LABORATORIES

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
43598-429Dimethyl FumarateDimethyl fumarateDr. Reddy's Laboratories Inc.ANDACurrent
43598-429Dimethyl FumarateDimethyl fumarateDr. Reddy's Laboratories Inc.ANDACurrent
43598-429Dimethyl FumarateDimethyl fumarateDr. Reddy's Laboratories Inc.ANDACurrent
43598-430Dimethyl FumarateDimethyl fumarateDr. Reddy's Laboratories Inc.ANDACurrent
43598-430Dimethyl FumarateDimethyl fumarateDr. Reddy's Laboratories Inc.ANDACurrent
43598-430Dimethyl FumarateDimethyl fumarateDr. Reddy's Laboratories Inc.ANDACurrent
69539-042Dimethyl FumarateDimethyl fumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-042Dimethyl FumarateDimethyl fumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-042Dimethyl FumarateDimethyl fumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-043Dimethyl FumarateDimethyl fumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-043Dimethyl FumarateDimethyl fumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-043Dimethyl FumarateDimethyl fumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-240Dimethyl FumarateDimethyl FumarateMSN LABORATORIES PRIVATE LIMITEDANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58380ORIG2019-04-24