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Federal Trade Commission
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Generated: August 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

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ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18229 A II 3/30/2005 MYLAN LABORATORIES LTD ABACAVIR SULFATE USP
18256 A II 3/24/2005 AUROBINDO PHARMA LTD ABACAVIR SULFATE USP
20515 A II 5/8/2007 OLON USA INC ABACAVIR SULFATE
22196 A II 11/17/2008 HETERO LABS LTD ABACAVIR SULFATE
23618 A II 4/8/2010 LUPIN LTD ABACAVIR SULFATE USP
23644 A II 3/19/2010 SIGNA SA DE CV ABACAVIR SULFATE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Express Scripts
Cantor Fitzgerald
AstraZeneca
Mallinckrodt
US Army
Covington
Fish and Richardson
Johnson and Johnson

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