NDC 0069-0193

BOSULIF

Bosutinib Monohydrate

BOSULIF 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 Bosutinib Monohydrate.

Product ID0069-0193_28ccd2f3-a7b1-44fa-8dab-cb6a88fffd27
NDC0069-0193
Product TypeHuman Prescription Drug
Proprietary NameBOSULIF
Generic NameBosutinib Monohydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-18
Marketing CategoryNDA / NDA
Application NumberNDA203341
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameBOSUTINIB MONOHYDRATE
Active Ingredient Strength400 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-0193-01

30 TABLET, FILM COATED in 1 BOTTLE (0069-0193-01)
Marketing Start Date2017-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0193-01 [00069019301]

BOSULIF TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203341
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-18

Drug Details

Active Ingredients

IngredientStrength
BOSUTINIB MONOHYDRATE400 mg/1

OpenFDA Data

SPL SET ID:adc84ad5-a04d-4fee-9ba8-91f7abd928e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1307624
  • 1987732
  • 1987734
  • 1307630
  • 1307633
  • 1307635
  • UPC Code
  • 0300690193014
  • 0300690136011
  • 0300690135014
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "BOSULIF" or generic name "Bosutinib Monohydrate"

    NDCBrand NameGeneric Name
    0069-0135BOSULIFBosutinib monohydrate
    0069-0136BOSULIFBosutinib monohydrate
    0069-0193BOSULIFBosutinib monohydrate
    63539-117BOSULIFBosutinib
    63539-193BOSULIFBosutinib

    Trademark Results [BOSULIF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BOSULIF
    BOSULIF
    85254857 4292873 Live/Registered
    Wyeth LLC
    2011-03-01
    BOSULIF
    BOSULIF
    77813503 3971238 Live/Registered
    WYETH LLC
    2009-08-26

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