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Generated: September 20, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Asta

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Asta Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13128 I V 8/12/1998 ASTA MEDICA INC TOXICOLOGY INFORMATION FOR PERIFOSINE (D-21266)
15262 A II 2/5/2001 AMPHASTAR FRANCE PHARMACEUTICALS SAS RECOMBINANT HUMAN INSULIN
16426 I III 2/14/2003 AMPHASTAR PHARMACEUTICALS INC PROCESSING FOR WASHING, DEPYROGENAING, SILICONIZING, STERILIZING AND PACKAGING OF STERILE STOPPERS
16587 I II 5/14/2003 MASTAFA NEVZAT ILAC SANAYII SULBACTAM SODIUM (NON-STERILE)
26059 A II 5/25/2012 AMPHASTAR NANJING PHARMACEUTICALS INC SEMI-PURIFIED HEPARIN SODIUM
27837 A II 3/6/2014 AMPHASTAR NANJING PHARMACEUTICALS INC BECLOMETHASONE DIPROPIONATE
29454 A II 6/29/2015 AMPHASTAR NANJING PHARMACEUTICALS INC FLUTICASONE PROPIONATE, 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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