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Generated: March 18, 2019

DrugPatentWatch Database Preview

Drug Master Files for: Hoffmann La Roche

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Hoffmann La Roche Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1007 I II 11/1/1966 HOFFMANN LA ROCHE INC COMPOSITION & GR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307
1037 I II 3/1/1967 HOFFMANN LA ROCHE INC PROTAMINE HCL, RO 6-1588/1
10481 I I 9/17/1993 HOFFMANN LA ROCHE INC FACILITY AND OPERATING PROCEDURES IN WELWYN GARDEN CITY, HERTFORDSHIRE, ENGLAND
10496 I II 9/24/1993 HOFFMANN LA ROCHE INC NITOMAN (TETRABENAZINE) TABLETS
19529 I II 6/19/2006 HOFFMANN LA ROCHE INC INTERLEUKIN-2 (HUMAN, RECOMBINANT, E. COLI, HOFFMAN-LA ROCHE)
2116 I II 6/21/1973 HOFFMANN LA ROCHE INC B-AMINOPROPIONITRILE FUMARATE
2162 I II 10/4/1973 HOFFMANN LA ROCHE INC R03-0749/607 DISODIUM PYRIDOXAL PHOSPHATE INJ
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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