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Last Updated: December 28, 2024

Drug Master Files for: QUINIDINE POLYGALACTURONATE


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QUINIDINE POLYGALACTURONATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12334 I II 1/24/1997 PT SINKONA INDONESIA LESTARI QUINIDINE GLUCONATE
2083 I II 3/8/1973 GYMA LABORATORIES AMERICA INC HYDROQUINIDINE ALGINATE
2723 I II 8/5/1976 SOCIETE CHIMIQUE POINTET GIRARD SA QUINIDINE GLUCONATE
2759 I II 8/10/1976 BUCHLER AND CO QUINIDINE SULFATE AND QUINIDINE PRODUCTS
2832 I II 1/28/1977 LAKE AND CRUICKSHANK QUINIDINE PRODUCTS
2871 I II 2/18/1977 PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKS QUINIDINE SULFATE
2902 I II 4/19/1977 SOCIETE CHIMIQUE POINTET GIRARD SA QUINIDINE SULFATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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