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Last Updated: December 22, 2024

Drug Master Files for: epinephrine


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epinephrine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
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
16344 A II 12/20/2002 CHEMPACIFIC CORP NOREPINEPHRINE BITARTRATE
21213 A II 12/31/2007 WOCKHARDT LTD Epinephrine USP
21716 A II 6/6/2008 AMRI RENSSELAER INC RACEPINEPHRINE HYDROCHLORIDE, USP DRUG SUBSTANCE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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