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Last Updated: November 2, 2024

Drug Master Files for: CROMOLYN SODIUM


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CROMOLYN SODIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10006 A II 12/15/1992 FERMION OY CROMOLYN SODIUM
10736 I II 2/18/1994 SOCIETA ITALIANA MEDICINALI SCANDICCI CROMOLYN SODIUM
11050 I II 8/26/1994 FARMHISPANIA SA CROMOLYN SODIUM
11724 I II 10/26/1995 LIPHA SAS CROMOLYN SODIUM
1581 I II 9/21/1970 AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND
1837 I 12/22/1971 FISONS CORP CROMOLYN SODIUM/LACTOSE BLEND
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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