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Last Updated: March 29, 2024

Drug Master Files for: loxapine succinate


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loxapine succinate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13135 I II 8/14/1998 INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD LOXAPINE BASE
23144 A II 9/30/2009 MEDICHEM SA LOXAPINE BASE
29977 A II 11/6/2015 CENTAUR PHARMACEUTICALS PRIVATE LTD LOXAPINE SUCCINATE USP
3447 I II 2/2/1979 AMERICAN CYANAMID CO LOXITANE (LOXAPINE SUCCINATE POWDER), AMOXAPINE
6767 A II 12/29/1986 MEDICHEM SA LOXAPINE SUCCINATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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