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Generated: June 26, 2019

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Drug Master Files for: CHOLINE FENOFIBRATE

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CHOLINE FENOFIBRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10598 I II 12/2/1993 GENZYME PHARMACEUTICALS SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC)
11247 A IV 12/12/1994 LIPOID GMBH LIPOID PC 14:0/14:0 (1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DMPC))
11407 I II 3/28/1995 AVANTI POLAR LIPIDS INC 1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE
11464 A II 4/12/1995 NOF CORP DIMYRISTOYL PHOSPHATIDYL CHOLINE
11561 I II 5/31/1995 NOF CORP PURIFIED EGG YOLK PHOSPHATIDYLCHOLINE
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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