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Last Updated: November 4, 2024

Drug Master Files for: SULFAPYRIDINE


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SULFAPYRIDINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1191 I 5/29/1968 AMERICAN CYANAMID CO SALICYLAZOSULFAPYRIDINE
1775 I 8/9/1971 CROMPTON AND KNOWLES CORP SALICYLAZOSULFAPYRIDINE
4091 I II 3/4/1981 ORGAMOL SA SALICYLAZOSULFAPYRIDINE (SULFASALAZINE)
5145 I II 10/18/1983 SCHERING AG SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT
6347 I II 5/19/1986 ACF CHEMIEFARMA NV SULFAPYRIDINE
6658 A II 10/29/1986 EUTICALS SPA SULFAPYRIDINE
7242 I II 11/9/1987 PROQUINA SA SALAZOSULFAPYRIDINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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