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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Department of Justice
Cerilliant
Federal Trade Commission
Chinese Patent Office
Teva
Moodys
Johnson and Johnson
Express Scripts

Generated: August 17, 2018

DrugPatentWatch Database Preview

Drug Master Files for: AZITHROMYCIN

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AZITHROMYCIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14079 I II 4/15/1999 PLIVA DD MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE
14480 I II 10/14/1999 WOCKHARDT LTD AZITHROMYCIN USP
15261 A II 1/24/2001 TEVA PHARMACEUTICAL INDUSTRIES LTD AZITHROMYCIN MONOHYDRATE
15972 A II 5/2/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD AZITHROMYCIN DIHYDRATE
15985 A II 5/28/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD AZITHROMYCIN N
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Fish and Richardson
Daiichi Sankyo
Mallinckrodt
UBS
QuintilesIMS
US Army
Medtronic
Express Scripts
Healthtrust

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