NDC 71332-001

TAVALISSE

Fostamatinib

TAVALISSE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rigel Pharmaceuticals, Inc.. The primary component is Fostamatinib.

Product ID71332-001_0ee88fed-f00f-4c05-9d26-579399ef38f4
NDC71332-001
Product TypeHuman Prescription Drug
Proprietary NameTAVALISSE
Generic NameFostamatinib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-09
Marketing CategoryNDA / NDA
Application NumberNDA209299
Labeler NameRigel Pharmaceuticals, Inc.
Substance NameFOSTAMATINIB
Active Ingredient Strength100 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71332-001-01

60 TABLET in 1 BOTTLE (71332-001-01)
Marketing Start Date2018-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71332-001-01 [71332000101]

TAVALISSE TABLET
Marketing CategoryNDA
Application NumberNDA209299
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-09
Inactivation Date2020-01-31
Reactivation Date2020-05-05

Drug Details

Active Ingredients

IngredientStrength
FOSTAMATINIB100 mg/1

OpenFDA Data

SPL SET ID:21149cc3-049b-43e2-b141-c9499160556c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2044930
  • 2044932
  • 2044922
  • 2044928
  • UPC Code
  • 0371332001011
  • NDC Crossover Matching brand name "TAVALISSE" or generic name "Fostamatinib"

    NDCBrand NameGeneric Name
    71332-001TAVALISSEFOSTAMATINIB
    71332-002TAVALISSEFOSTAMATINIB

    Trademark Results [TAVALISSE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TAVALISSE
    TAVALISSE
    87407547 not registered Live/Pending
    Rigel Pharmaceuticals, Inc.
    2017-04-11
    TAVALISSE
    TAVALISSE
    87144949 5638421 Live/Registered
    Rigel Pharmaceuticals, Inc.
    2016-08-19

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