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Generated: November 13, 2018

DrugPatentWatch Database Preview

Drug Master Files for: phentolamine

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phentolamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11936 I II 4/19/1996 SYNKEM DIV PLASTO SA PHENTOLAMINE MESYLATE
12260 A II 12/11/1996 RELIABLE BIOPHARMACEUTICAL LLC PHENTOLAMINE MESYLATE, USP
16428 A II 2/13/2003 INDUSTRIALE CHIMICA SRL PHENTOLAMINE MESILATE USP
28193 A II 6/16/2014 APICORE US LLC PHENTOLAMINE MESYLATE, USP
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Healthtrust
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Baxter
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Cantor Fitzgerald
Farmers Insurance
US Army
Queensland Health
Julphar

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