NDC 55135-132

TRODELVY

Sacituzumab Govitecan

TRODELVY is a Intravenous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Immunomedics, Inc.. The primary component is Sacituzumab Govitecan.

Product ID55135-132_03cd6297-513e-469a-a1d1-da5400fb5099
NDC55135-132
Product TypeHuman Prescription Drug
Proprietary NameTRODELVY
Generic NameSacituzumab Govitecan
Dosage FormPowder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-22
Marketing CategoryBLA / BLA
Application NumberBLA761115
Labeler NameImmunomedics, Inc.
Substance NameSACITUZUMAB GOVITECAN
Active Ingredient Strength180 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55135-132-01

1 VIAL in 1 BOX (55135-132-01) > 1 POWDER, FOR SOLUTION in 1 VIAL
Marketing Start Date2020-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55135-132-01 [55135013201]

TRODELVY POWDER, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA761115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-23

Drug Details

Active Ingredients

IngredientStrength
SACITUZUMAB GOVITECAN180 mg/1

OpenFDA Data

SPL SET ID:57a597d2-03f0-472e-b148-016d7169169d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2360539
  • 2360534
  • UPC Code
  • 0355135132011

  • Trademark Results [TRODELVY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRODELVY
    TRODELVY
    90764802 not registered Live/Pending
    IMMUNOMEDICS, INC.
    2021-06-09
    TRODELVY
    TRODELVY
    90514477 not registered Live/Pending
    IMMUNOMEDICS, INC.
    2021-02-05
    TRODELVY
    TRODELVY
    88064964 not registered Live/Pending
    IMMUNOMEDICS, INC.
    2018-08-03
    TRODELVY
    TRODELVY
    87684433 not registered Live/Pending
    IMMUNOMEDICS, INC.
    2017-11-14

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.