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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Argus Health
Daiichi Sankyo
Fuji
Merck
Novartis
Teva
Cipla
Chubb

Generated: December 12, 2017

DrugPatentWatch Database Preview

Drug Master Files for: AZITHROMYCIN

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DMF No. Status Type Submission Date Holder Subject
14079III4/15/1999PLIVA DDMANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE
14480III10/14/1999WOCKHARDT LTDAZITHROMYCIN USP
15261AII1/24/2001TEVA PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN MONOHYDRATE
15972AII5/2/2002TEVA PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN DIHYDRATE
15985AII5/28/2002TEVA PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN N
16268III11/25/2002WOCKHARDT LTDAZITHROMYCIN-FORM I
16390AII1/30/2003SANDOZ INDUSTRIAL PRODUCTS SAAZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)
17010III2/28/2005ITF CHEMICAL LTDAAZITHROMYCIN MONOHYDRATE
17091III12/31/2003ALEMBIC LTD API DIVAZITHROMYCIN MONOHYDRATE
17951III12/29/2004QUIMICA SINTETICA SAAZITHROMYCIN HYDROGENCITRATE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Chinese Patent Office
Teva
Colorcon
Julphar
Covington
Cerilliant
Queensland Health
Argus Health
Citi
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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