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Details for New Drug Application (NDA): 203341

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NDA 203341 describes BOSULIF, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the BOSULIF profile page.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are three 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 NDA: 203341

Wyeth Pharms Inc
bosutinib monohydrate

Pharmacology for NDA: 203341

Suppliers and Packaging for NDA: 203341

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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
Patent:7,767,678Patent Expiration:Nov 23, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:7,919,625Patent Expiration:Dec 11, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:RE42376Patent Expiration:Sep 24, 2019Product Flag?Substance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.