NDC 0069-1531

Daurismo

Glasdegib

Daurismo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Glasdegib.

Product ID0069-1531_1b683310-8e38-4505-acd8-b92006bc2488
NDC0069-1531
Product TypeHuman Prescription Drug
Proprietary NameDaurismo
Generic NameGlasdegib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-12-10
Marketing CategoryNDA / NDA
Application NumberNDA210656
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameGLASDEGIB
Active Ingredient Strength100 mg/1
Pharm ClassesHedgehog Pathway Inhibitor [EPC],Smoothened Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-1531-30

30 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30)
Marketing Start Date2018-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-1531-30 [00069153130]

Daurismo TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-10

Drug Details

Active Ingredients

IngredientStrength
GLASDEGIB100 mg/1

OpenFDA Data

SPL SET ID:204a6f7e-c9a4-472b-abd2-9527bda64d17
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2105850
  • 2105860
  • 2105856
  • 2105858
  • UPC Code
  • 0300690298603
  • 0300691531303
  • Pharmacological Class

    • Hedgehog Pathway Inhibitor [EPC]
    • Smoothened Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "Daurismo" or generic name "Glasdegib"

    NDCBrand NameGeneric Name
    0069-0298Daurismoglasdegib
    0069-1531Daurismoglasdegib

    Trademark Results [Daurismo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DAURISMO
    DAURISMO
    88980015 not registered Live/Pending
    Pfizer Inc.
    2018-12-04
    DAURISMO
    DAURISMO
    88215704 not registered Live/Pending
    Pfizer Inc.
    2018-12-04
    DAURISMO
    DAURISMO
    87936058 not registered Live/Pending
    Pfizer Inc.
    2018-05-25
    DAURISMO
    DAURISMO
    86454277 not registered Dead/Abandoned
    Pfizer Inc.
    2014-11-14

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