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Serving leading biopharmaceutical companies globally:

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Generated: February 23, 2018

DrugPatentWatch Database Preview

Drug Master Files for: drospirenone

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DMF No. Status Type Submission Date Holder Subject
12138AII9/9/1996BAYER AGDROSPIRENONE
17866AII12/3/2004GEDEON RICHTER PLCDROSPIRENONE USP
19461III5/23/20063M DRUG DELIVERY SYSTEMS DIVDROSPIRENONE/ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM
20676AII7/11/2007INDUSTRIALE CHIMICA SRLDROSPIRENONE USP
21733AII6/27/2008STERLING SPADROSPIRENONE
22802AII5/15/2009NEWCHEM SPADROSPIRENONE
22878AII6/18/2009TEVA PHARMACEUTICAL INDUSTRIES LTDDROSPIRENONE
23397AII1/12/2010LUPIN LTDDROSPIRENONE USP
23580AII8/16/2010SUN PHARMACEUTICAL INDUSTRIES LTDDROSPIRENONE USP
25796III2/17/2012CRYSTAL PHARMA SAUDROSPIRENONE NON MICRONIZED AND MICRONIZED
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Federal Trade Commission
Deloitte
Citi
US Department of Justice
US Army
Queensland Health
McKinsey
Chinese Patent Office
Mallinckrodt
Express Scripts

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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