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Generated: September 23, 2018

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Drug Master Files for: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

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BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11938 A II 4/18/1996 SIEGFRIED EVIONNAZ SA BUPIVACAINE BASE
19177 A II 2/10/2006 CAMBREX KARLSKOGA AB BUPIVACAINE BASE
20959 A II 10/18/2007 DISHMAN CARBOGEN AMCIS LTD BUPIVACAINE HYDROCHLORIDE
21196 A II 12/20/2007 EXCELLA GMBH AND CO KG Bupivacaine Hydrochloride
22228 A II 11/24/2008 MOEHS IBERICA SL BUPIVACAINE HYDROCHLORIDE
25090 I II 7/27/2011 EXCELLA GMBH BUPIVACAINE (S) HYDROCHLORIDE
26649 I II 12/28/2012 FRESENIUS KABI ONCOLOGY LTD BUPIVACAINE HYDROCHLORIDE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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