Home Applications 022505 Application 022505
Type BLA
Sponsor THERATECHNOLOGIES Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022505 Egrifta tesamorelin 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EGRIFTA TESAMORELIN ACETATE POWDER;SUBCUTANEOUS EQ 1MG BASE/VIAL No No 002 EGRIFTA TESAMORELIN ACETATE POWDER;SUBCUTANEOUS EQ 2MG BASE/VIAL No No
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62064-011 Egrifta tesamorelin Theratechnologies Inc. NDA Current 62064-011 Egrifta tesamorelin Theratechnologies Inc. NDA Current 62064-011 Egrifta tesamorelin Theratechnologies Inc. BLA Current 62064-011 Egrifta tesamorelin Theratechnologies Inc. BLA Current 62064-041 Egrifta tesamorelin Theratechnologies Inc. NDA Current 62064-241 EGRIFTA SV tesamorelin Theratechnologies Inc. NDA Current 62064-241 EGRIFTA SV tesamorelin Theratechnologies Inc. BLA Current 62064-241 EGRIFTA SV tesamorelin Theratechnologies Inc. BLA Current 62064-241 EGRIFTA SV tesamorelin Theratechnologies Inc. BLA Current