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Last Updated: November 20, 2019

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Drug Master Files for: Otsuka

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Otsuka Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10257 I II 5/20/1993 OTSUKA PHARMACEUTICAL CO LTD FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN
12418 I II 3/1/1997 OTSUKA PHARMACEUTICAL CO LTD NADIFLOXACIN DRUG SUBSTANCE
13285 I II 10/15/1998 OTSUKA PHARMACEUTICAL CO LTD NO-1886 DRUG SUBSTANCE
15001 I II 8/10/2000 OTSUKA PHARMACEUTICAL CO LTD REBAMIPIDE(OPC-12759) DRUG SUBSTANCE
20451 I II 4/10/2007 OTSUKA CHEMICAL CO LTD P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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