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Generated: August 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

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EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
3875 I II 7/4/1980 3M PHARMACEUTICALS ADRENALINE (EPINEPHRINE) AND SALTS OF EPINEPHRINE
5779 A II 5/4/1984 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG EPINEPHRINE HYDROGENTARTRATE
5822 A II 5/29/1985 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG EPINEPHRINE
12037 A II 7/10/1996 CAMBREX PROFARMACO MILANO SRL NOREPINEPHRINE BITARTRATE OR NORADRENALINE ACID TARTRATE
15367 I II 3/30/2001 WUHAN WUYAO PHARMACEUTICAL CO LTD NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKinsey
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Dow
Queensland Health
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McKesson
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Baxter

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