FDA.reportPublic FDA data

Application 208745

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRULANCEPLECANATIDETABLET;ORAL3MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix PharmaceuticalsNDACurrent
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix PharmaceuticalsNDACurrent
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix Pharmaceuticals Inc.NDACurrent
65649-003TrulancePlecanatideSalix PharmaceuticalsNDACurrent
70194-003TrulancePlecanatideSynergy Pharmaceuticals Inc.NDACurrent
70194-003TrulancePlecanatideSynergy Pharmaceuticals Inc.NDACurrent
70194-003TrulancePlecanatideSynergy Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67083SUPPL2021-04-16
67082SUPPL2021-04-16
67054SUPPL2021-04-14
66247SUPPL2021-02-17
66246SUPPL2021-02-17
66196SUPPL2021-02-11
65556SUPPL2020-12-10
65119SUPPL2020-11-02
65079SUPPL2020-10-30
65078SUPPL2020-10-30
65077SUPPL2020-10-30
65073SUPPL2020-10-29
55016SUPPL2018-07-26
52106SUPPL2018-01-30
51919SUPPL2018-01-26
51918SUPPL2018-01-24
47466ORIG2017-03-03
46927ORIG2017-01-23
46926ORIG2017-01-23