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Last Updated: November 14, 2024

Drug Master Files for: etomidate


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etomidate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10635 I II 12/17/1993 JANSSEN PHARMACEUTICA NV ETOMIDATE
11229 A II 11/15/1994 RELIABLE BIOPHARMACEUTICAL LLC ETOMIDATE
15983 A II 5/24/2002 PISGAH LABS INC ETOMIDATE
20234 A II 1/29/2007 BACHEM SA ETOMIDATE
20500 A II 4/30/2007 CHEMWERTH INC ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE
27580 A II 9/20/2013 SOLARA A PHARMA SCIENCES LTD ETOMIDATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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