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Generated: October 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: NILOTINIB HYDROCHLORIDE

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NILOTINIB HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
25338 I II 9/28/2011 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1)
25412 I II 10/19/2011 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1)
26497 I II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD NILOTINIB
28102 A II 7/15/2014 TEVA PHARMACEUTICAL INDUSTRIES LTD NILOTINIB HYDROCHLORIDE
30088 A II 12/31/2015 DR REDDYS LABORATORIES LTD NILOTINIB HYDROCHLORIDE
30098 A II 12/9/2015 HETERO LABS LTD NILOTINIB HYDROCHLORIDE DIHYDRATE
30164 A II 12/29/2015 HIKMA PHARMACEUTICALS PLC NILOTINIB MONOHYDROCHLORIDE ANHYDROUS
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Covington

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