FDA.reportPublic FDA data

Application 022505

Type
BLA
Sponsor
THERATECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EGRIFTATESAMORELIN ACETATEPOWDER;SUBCUTANEOUSEQ 1MG BASE/VIALNoNo
002EGRIFTATESAMORELIN ACETATEPOWDER;SUBCUTANEOUSEQ 2MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62064-011EgriftatesamorelinTheratechnologies Inc.BLACurrent
62064-011EgriftatesamorelinTheratechnologies Inc.BLACurrent
62064-011EgriftatesamorelinTheratechnologies Inc.NDACurrent
62064-011EgriftatesamorelinTheratechnologies Inc.NDACurrent
62064-041EgriftatesamorelinTheratechnologies Inc.NDACurrent
62064-241EGRIFTA SVtesamorelinTheratechnologies Inc.BLACurrent
62064-241EGRIFTA SVtesamorelinTheratechnologies Inc.BLACurrent
62064-241EGRIFTA SVtesamorelinTheratechnologies Inc.BLACurrent
62064-241EGRIFTA SVtesamorelinTheratechnologies Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81743SUPPL 2025-03-27
81739SUPPL 2025-03-26
77642SUPPL 2024-02-28
77641SUPPL 2024-02-28
59305SUPPL2020-03-23
59304SUPPL2020-03-23
59267SUPPL2020-03-23
59266SUPPL2020-03-23
58034SUPPL2020-03-23
58019SUPPL2020-03-23
57285SUPPL2020-03-23
38774SUPPL2020-03-23
38773SUPPL2020-03-23
38772SUPPL2020-03-23
38771ORIG2020-03-23
29793ORIG2020-03-23
24327ORIG2020-03-23
22039ORIG2020-03-23
17654SUPPL2020-03-23
7466SUPPL2020-03-23
66428APPL2020-03-22