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Generated: August 23, 2019

DrugPatentWatch Database Preview

Drug Master Files for: CYSTEAMINE HYDROCHLORIDE

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CYSTEAMINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
2597 I II 1/16/1976 SIGMA F AND D DIV LTD B-MERCAPTOCTHYLAMINE HYDROCHLORIDE (CYSTEAMINE)
26816 A II 9/5/2013 ACIC FINE CHEMICALS INC CYSTEAMINE BITARTRATE
27574 A II 7/25/2013 CAMBREX PROFARMACO MILANO SRL CYSTEAMINE BITARTRATE (RP)
32668 A II 4/13/2018 LUPIN LTD CYSTEAMINE BITARTRATE
7405 I II 3/26/1988 MEDEA RESEARCH LABORATORIES INC PHOSPHOCYSTEAMINE
9619 A II 9/30/1992 CAMBREX PROFARMACO MILANO SRL CYSTEAMINE BITARTRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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