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Last Updated: December 22, 2024

Drug Master Files for: DESIPRAMINE HYDROCHLORIDE


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DESIPRAMINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10461 A II 9/8/1993 PCAS DESIPRAMINE HYDROCHLORIDE
3374 A II 10/4/1978 LUNDBECK PHARMACEUTICALS ITALY SPA DESIPRAMINE HYDROCHLORIDE
5367 I II 4/20/1984 FARCHEMIA SRL DESIPRAMINE HYDROCHLORIDE USP
6012 A II 9/9/1985 PCAS DESIPRAMINE HCL
6643 I II 10/21/1986 IRISH FINE CHEMICALS LTD DESIPRAMINE HYDROCHLORIDE
6663 I II 11/5/1986 ACF CHEMIEFARMA NV DESIPRAMINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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