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Last Updated: November 22, 2024

Drug Master Files for: KETAMINE HYDROCHLORIDE


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KETAMINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13141 I II 8/18/1998 DEGUSSA AG WERK RADEBEUL KETAMINE HYDROCHLORIDE
16737 A II 7/31/2003 CU CHEMIE UETIKON GMBH S-KETAMINE HYDROCHLORIDE
19082 A II 12/16/2005 FINE ORGANICS LTD KETAMINE HYDROCHLORIDE
22256 I II 11/28/2008 KAMUD DRUGS PVT LTD KETAMINE HYDROCHLORIDE USP
27921 A II 1/15/2014 SUPRIYA LIFESCIENCE LTD KETAMINE HYDROCHLORIDE USP
29094 A II 4/14/2015 AREVIPHARMA GMBH KETAMINE HYDROCHLORIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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