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Last Updated: March 28, 2024

Drug Master Files for: benzphetamine


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benzphetamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16687 I II 7/9/2003 CHEMICA INC BENZPHETAMINE HYDROCHLORIDE
18893 A II 10/21/2005 CHATTEM CHEMICALS INC BENZPHETAMINE HYDROCHLORIDE
20563 I II 5/30/2007 SIEGFRIED LTD BENZPHETAMINE HYDROCHLORIDE
21090 I II 11/26/2007 CORDEN PHARMACHEM Benzphetamine Hydrochloride
21319 A II 2/5/2008 OLON SPA BENZPHETAMINE HYDROCHLORIDE
22040 I II 9/29/2008 MALLINCKRODT INC BENZPHETAMINE HYDROCHLORIDE, CODE 9223
23944 A II 7/6/2010 EMCURE PHARMACEUTICALS LTD BENZPHETAMINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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