Application 074819

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67296-0595ETODOLACetodolacRedPharm Drug Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53916ORIG2018-05-01