FDA.reportPublic FDA data

Application 210382

Type
ANDA
Sponsor
TWI PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-127dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
24979-127dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
24979-127dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
24979-128dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
24979-128dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
24979-128dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
24979-129dimethyl fumaratedimethyl fumarateTWi Pharmaceuticals, Inc.ANDACurrent
51407-441dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-441dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-441dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-441dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-441dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-442dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-442dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-442dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-442dimethyl fumaratedimethyl fumarateGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57786ORIG2019-02-22