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Last Updated: November 2, 2024

Drug Master Files for: TICLOPIDINE HYDROCHLORIDE


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TICLOPIDINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10492 A II 9/15/1993 SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL TICLOPIDINE HYDROCHLORIDE
11664 A II 9/21/1995 TEVA PHARMACEUTICAL INDUSTRIES LTD TICLOPIDINE HCL
11968 A II 5/17/1996 ERREGIERRE SPA TICLOPIDINE HYDROCHLORIDE
12643 A II 9/4/1997 EUTICALS SPA TICLOPIDINE HYDROCHLORIDE
22355 I II 12/30/2008 AARTI DRUGS LTD TICLOPIDINE HYDROCHLORIDE
3599 I II 8/22/1979 ORGAMOL SA TICLOPIDINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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