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Serving leading biopharmaceutical companies globally:

Medtronic
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203341

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NDA 203341 describes BOSULIF, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BOSULIF profile page.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.

Summary for 203341

Tradename:1
Applicant:1
Ingredient:1
Patents:5

Pharmacology for NDA: 203341

Suppliers and Packaging for NDA: 203341

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BOSULIF bosutinib monohydrate TABLET;ORAL 203341 NDA Pfizer Laboratories Div Pfizer Inc 0069-0135 0069-0135-01 120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01)
BOSULIF bosutinib monohydrate TABLET;ORAL 203341 NDA Pfizer Laboratories Div Pfizer Inc 0069-0136 0069-0136-01 30 TABLET, FILM COATED in 1 BOTTLE (0069-0136-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Sep 4, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 4, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 4, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Mar 27, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING A NEOPLASM


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Serving leading biopharmaceutical companies globally:

Covington
Novartis
Medtronic
Cantor Fitzgerald
Moodys
US Department of Justice
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Dow
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Colorcon

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