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Last Updated: March 29, 2024

Drug Master Files for: fish


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fish Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24996 A II 5/27/2011 ZHOUSHAN SINOMEGA BIOTECH ENGINEERING CO LTD OMEGA-3 REFINED FISH OIL
25420 A II 11/22/2011 DSM NUTRITIONAL PRODUCTS CANADA INC HIGH EPA INTERMEDIATE FISH OIL
26880 I II 3/21/2013 CI NATURMEGA SA OMEGA-3 FISH OIL ETHYL ESTER 84%
29727 A II 9/1/2015 CHEMPORT INC E130D90TG(FISH OIL CONTAINING OMEGA-3 ACIDS)
7436 I II 3/30/1988 NATL INST HLTH ADAMHA DOC INFORMATION ON FISH OILS AS SUBMITTED ON BEHALF OF FOTMAC
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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