FDA.reportPublic FDA data

Application 200671

Type
NDA
Sponsor
ESPERO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DURLAZAASPIRINCAPSULE, EXTENDED RELEASE;ORAL162.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58487-001DURLAZAAcetylsalicylic AcidNew Haven Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46069ORIG2016-09-30
18974SUPPL2015-12-10
40038SUPPL2015-10-22
32046SUPPL2015-10-02
9839SUPPL2015-09-17
32045ORIG2015-09-15
18973ORIG2015-09-14