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Generated: November 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Roche

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Roche Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1007 I II 11/1/1966 HOFFMANN LA ROCHE INC COMPOSITION & MFGR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307
10092 I III 2/18/1993 SABIC PETROCHEMICALS BV SABIC LDPE 2100TN00
10093 I III 2/18/1993 SABIC PETROCHEMICALS BV SABIC LDPE 2200TC00
10094 I III 2/18/1993 SABIC PETROCHEMICALS BV SABIC LDPE 2200TC12
10141 I III 3/1/1993 MITSUI PETROCHEMICAL AMERICA LTD ADMER Q F 500 A
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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