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Generated: January 21, 2019

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Drug Master Files for: hydromorphone

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hydromorphone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12098 A II 8/20/1996 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS HYDROMORPHONE HCL
16351 A II 12/6/2002 RHODES TECHNOLOGIES HYDROMORPHONE HYDROCHLORIDE USP
17501 A II 6/14/2004 CODY LABORATORIES INC HYDROMORPHONE HYDROCHOLORIDE USP
18834 I II 9/30/2005 MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIEN HYDROMORPHONE BASE
19561 A II 6/29/2006 NORAMCO INC HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE
19846 A II 10/6/2006 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS HYDROMORPHONE HCI, USP
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Johnson and Johnson
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McKinsey
Fish and Richardson
Chinese Patent Office
Harvard Business School

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