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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:203341Orig1s000 CHEMISTRY REVIEW(S)OND QA Division Directors Memo NDA 203341, Bosnia (bosutinib) Tablets Date: 27JUL2012Introduction BOSNIA
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NDA 203341 is a New Drug Application for the drug Bosulif (bosutinib), which is used for the treatment of certain types of leukemia.
The pharmaceutical company developing Bosulif (bosutinib) is required to file NDA 203341 with the FDA.
NDA 203341 for Bosulif (bosutinib) must be filled out according to FDA guidelines and regulations for New Drug Applications.
The purpose of NDA 203341 for Bosulif (bosutinib) is to seek FDA approval for the drug to be marketed and sold for the treatment of leukemia.
NDA 203341 for Bosulif (bosutinib) must include clinical trial data, safety information, efficacy results, manufacturing details, and labeling information.
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