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Generated: September 16, 2019

DrugPatentWatch Database Preview

Drug Master Files for: levothyroxine

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levothyroxine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14256 I II 6/29/1999 RHODIA INDUSTRIE CHIMIQUE MULHOUSE DORNACH LEVOTHYROXINE SODIUM USP
14715 A II 2/1/2000 PEPTIDO GMBH LEVOTHYROXINE SODIUM
24402 A II 10/20/2011 EXCELLA GMBH AND CO KG LEVOTHYROXINE SODIUM
25818 I II 2/20/2012 APOTEX PHARMACHEM INDIA PVT LTD LEVOTHYROXINE SODIUM USP
29098 A II 3/14/2015 AZICO BIOPHORE INDIA PVT LTD LEVOTHYROXINE SODIUM
29550 A II 7/27/2015 GLAND PHARMA LTD LEVOTHYROXINE SODIUM USP
30113 I II 3/1/2016 APOTEX PHARMACHEM INDIA PVT LTD LEVOTHYROXINE SODIUM USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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