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Last Updated: November 13, 2024

Drug Master Files for: sodium nitrite


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sodium nitrite Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10 I 2/23/1944 HERCULES POWDER CO SODIUM CARBOXYMETHYLCELLULOSE
1000 I 9/15/1966 GENERAL FOODS CORP MONSODIUM DIHYDROGEN PHOSPHATE
10003 A II 11/25/1992 ACS DOBFAR SPA SODIUM CARBONATE STERILE
10006 A II 12/15/1992 FERMION OY CROMOLYN SODIUM
10009 I V 7/30/1990 ASTELLAS PHARMA INC STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN
10030 I II 1/5/1993 ARES SERONO SA SODIUM CHLORIDE FOR INJECTION
10052 I II 12/9/1992 DIOSYNTH BV HEPARIN SODIUM
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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