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Serving leading biopharmaceutical companies globally:

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Generated: November 21, 2017

DrugPatentWatch Database Preview

Drug Master Files for: dexlansoprazole

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DMF No. Status Type Submission Date Holder Subject
29035AII3/30/2015APOTEX PHARMACHEM INCDEXLANSOPRAZOLE ANHYDRATE
22607AII3/12/2009DR REDDYS LABORATORIES LTDDEXLANSOPRAZOLE (AMORPHOUS)
23380AII12/16/2009DIPHARMA FRANCIS SRLDEXLANSOPRAZOLE
23655AII3/22/2010DR REDDYS LABORATORIES LTDDEXLANSOPRAZOLE (CRYSTALLINE)
23722AII4/19/2010MSN LABORATORIES PRIVATE LTDDEXLANSOPRAZOLE ANHYDROUS [ROUTE CODE - DZ]
24503AII12/21/2010MYLAN LABORATORIES LTDDEXLANSOPRAZOLE SESQUIHYDRATE
24815AII4/1/2011MSN LABORATORIES PRIVATE LTDDEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE - DP]
24875AII4/15/2011DIPHARMA FRANCIS SRLDEXLANSOPRAZOLE ANHYDROUS
25111AII6/30/2011MYLAN LABORATORIES LTDDEXLANSOPRAZOLE AMORPHOUS
25235AII8/31/2011ORCHID CHEMICALS AND PHARMACEUTICALS LTDDEXLANSOPRAZOLE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Dow
Cantor Fitzgerald
Fuji
Novartis
Merck
US Army
UBS
Express Scripts
Chubb
AstraZeneca

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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