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Drug Master Files for: IMATINIB

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DMF No. Status Type Submission Date Holder Subject
19499AII6/6/2006SUN PHARMACEUTICAL INDUSTRIES LTDIMATINIB MESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA.
20410AII4/5/2007NATCO PHARMA LTDIMATINIB METHANE SULFONATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA
21006AII11/2/2007TEVA PHARMACEUTICAL INDUSTRIES LTDImatinib Mesylate as manufactured by Sicor de Mexico S.A. de C.V. in Estado de Mexico, Mexico and Sicor S.r.l. in Rho, Italy for Teva Pharmaceutical Industries
23139AII10/1/2009MYLAN LABORATORIES LIMITEDIMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA
23343AII11/30/2009ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDIMATINIB MESYLATE AS MANUFACTURED IN ZHEJIANG CHINA
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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