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Last Updated: March 28, 2024

Drug Master Files for: tizanidine


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tizanidine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15525 A II 7/4/2001 FARMAK AS TIZANIDINE HCL
15555 I II 7/30/2001 FARCHEMIA SRL TIZANIDINE HYDROCHLORIDE
15699 A II 11/2/2001 DR REDDYS LABORATORIES LTD TIZANIDINE HYDROCHLORIDE USP
15727 A II 10/31/2001 SUN PHARMACEUTICAL INDUSTRIES LTD TIZANIDINE HYDROCHLORIDE USP
15730 I II 11/14/2001 HETERO DRUGS LTD TIZANIDINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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