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  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Julphar
Colorcon
Federal Trade Commission
Merck
Boehringer Ingelheim
Covington
Argus Health
US Army
Chubb
Medtronic

Generated: November 21, 2017

DrugPatentWatch Database Preview

Drug Master Files for: Lek Pharm

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DMF No. Status Type Submission Date Holder Subject
4289III9/29/1981LEK PHARMACEUTICAL AND CHEMICAL CO DDCALCIUM (GLUCOHYTONATE) GLUCEPTATE
4293III9/29/1981LEK PHARMACEUTICAL AND CHEMICAL CO DDLITHIUM CARBONATE
4297AII9/29/1981LEK PHARMACEUTICALS DDSILVER SULFADIAZINE
4303III9/29/1981LEK PHARMACEUTICAL AND CHEMICAL CO DDFDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY MONOTHERAPY CLINICAL TRIALS
4458III2/24/1982LEK PHARMACEUTICAL AND CHEMICAL CO DDPROPRANOLOL HCL
6335III3/21/1986LEK PHARMACEUTICAL AND CHEMICAL CO DDNIFEDIPINE
6827AII2/13/1987LEK PHARMACEUTICALS DDBROMOCRIPTINE MESYLATE USP
7863III12/13/1988LEK PHARMACEUTICAL AND CHEMICAL CO DDCIMETIDINE HCL
8292III11/16/1989LEK PHARMACEUTICAL AND CHEMICAL CO DDAURANOFIN
13114III8/6/1998LEK PHARMACEUTICALS DDENALAPRIL MALEATE, A SUBSTANCE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKinsey
Cipla
Federal Trade Commission
Queensland Health
Harvard Business School
Express Scripts
Accenture
Boehringer Ingelheim
Medtronic
McKesson

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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