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Generated: December 12, 2018

DrugPatentWatch Database Preview

Drug Master Files for: MORPHINE SULFATE

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MORPHINE SULFATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11529 I II 7/6/1995 MALLINCKRODT INC MORPHINE SULFATE INJECTION USP
12808 I II 12/23/1997 ELAN PHARMA LTD MORPHINE SULFATE
12818 A II 1/7/1998 SANOFI CHIMIE APOMORPHINE HYDROCHLORIDE
13188 A II 9/11/1998 MACFARLAN SMITH LTD APOMORPHINE HYDROCHLORIDE
14641 I II 12/23/1999 ARADIGM CORP AERX MORPHINE SULFATE PAIN MANAGEMENT SYSTEM
16433 I II 2/21/2003 ALKERMES INC AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG
17752 I II 9/30/2004 MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIEN MORPHINE ALKALOID, CODE 1547
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Express Scripts
Colorcon
Argus Health
Healthtrust
Dow
Covington
Queensland Health
QuintilesIMS
Julphar

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