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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Army
Moodys
Julphar
Federal Trade Commission
Johnson and Johnson

Generated: September 15, 2019

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Drug Master Files for: lanthanum

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lanthanum Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12722 I II 11/5/1997 JOHNSON MATTHEY INC LANTHANUM CARBONATE
18786 I II 9/19/2005 BOEHRINGER INGELHEIM CHEMICALS INC LANTHANUM CARBONATE HYDRATE
21958 A II 9/5/2008 MYLAN LABORATORIES LTD LANTHANUM CARBONATE
22050 A II 10/2/2008 NATCO PHARMA LTD LANTHANUM CARBONATE DIHYDRATE
22094 A II 10/17/2008 EXCELLA GMBH AND CO KG LANTHANUM CARBONATE
23254 A II 11/5/2009 UNIMARK REMEDIES LTD LANTHANUM CARBONATE OCTAHYDRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
AstraZeneca
Fish and Richardson
Argus Health
Moodys
Medtronic

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