Home Applications 761115 Application 761115
Type BLA
Sponsor IMMUNOMEDICS INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761115 Trodelvy sacituzumab govitecan-hziy 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRODELVY SACITUZUMAB GOVITECAN-HZIY INJECTABLE;INJECTION 180MG Yes 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRODELVY SACITUZUMAB GOVITECAN Gilead Sciences, Inc. 57a597d2-03f0-472e-b148-016d7169169d 2026-06-24 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761115 ndc (product): 55135-132
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55135-132 TRODELVY SACITUZUMAB GOVITECAN Immunomedics, Inc. BLA Current 55135-132 TRODELVY SACITUZUMAB GOVITECAN Gilead Sciences BLA Current 55135-132 TRODELVY SACITUZUMAB GOVITECAN Gilead Sciences BLA Current 55135-132 TRODELVY SACITUZUMAB GOVITECAN Gilead Sciences BLA Current 55135-132 TRODELVY SACITUZUMAB GOVITECAN Immunomedics, Inc. BLA Current 55135-132 TRODELVY SACITUZUMAB GOVITECAN Gilead Sciences BLA Current 55135-132 TRODELVY SACITUZUMAB GOVITECAN Immunomedics, Inc. BLA Current