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Generated: December 9, 2018

DrugPatentWatch Database Preview

Drug Master Files for: NALOXONE HYDROCHLORIDE

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NALOXONE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14034 A II 3/19/1999 ASPEN OSS BV NALOXONE HYDROCHLORIDE
1862 A II 1/25/1972 SPECGX LLC NALOXONE HCL USP DIHYDRATE
20745 A II 7/31/2007 MACFARLAN SMITH LTD Naloxone Hydrochloride
23142 A II 9/30/2009 SANOFI CHIMIE NALOXONE HYDROCHLORIDE
23389 A II 2/22/2010 SUN PHARMACEUTICAL INDUSTRIES LTD NALOXONE HYDROCHLORIDE DIHYDRATE USP
24633 A II 2/15/2011 NORAMCO GMBH NALOXONE HYDROCHLORIDE DRUG SUBSTANCE
24668 A II 2/24/2011 SIEGFRIED LTD NALOXONE HYDROCHLORIDE DIHYDRATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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