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Last Updated: November 4, 2024

Drug Master Files for: LEUCOVORIN CALCIUM


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LEUCOVORIN CALCIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10232 I II 3/6/1993 LABOCHIM SPA LEUCOVORIN CALCIUM
16718 I II 7/18/2003 GMT FINE CHEMCALS SA LEUCOVORIN CALCIUM, USP
25198 A II 8/10/2011 GMT FINE CHEMICALS SA LEVOLEUCOVORIN CALCIUM
25334 I II 8/9/2011 ALP PHARM BEIJING CO LTD LEUCOVORIN CALCIUM
3715 I II 2/11/1980 CYANAMID GMBH LEUCOVORIN CALCIUM
5046 A II 6/30/1983 CERBIOS PHARMA SA LEUCOVORIN CALCIUM
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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