FDA.reportPublic FDA data

Application 022505

Type
BLA
Sponsor
THERATECHNOLOGIES

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022505Egriftatesamorelin351(a)Disc2026-09-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EGRIFTA WRTESAMORELINTheratechnologies Inc.839334d3-8c1d-4c26-9036-2ab524a6ea752026-07-29Warnings, Adverse reactionsExact identifier
application number: BLA022505
EGRIFTA SVTESAMORELINTheratechnologies Inc.3d783378-b02d-4f19-99dd-0fc91a0422242026-07-29Warnings, Adverse reactionsExact identifier
application number: BLA022505
ndc (product): 62064-241

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

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

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