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Last Updated: November 23, 2024

Drug Master Files for: CICLESONIDE


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CICLESONIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12464 A III 4/10/1997 3M DRUG DELIVERY SYSTEMS PACKAGING MATERIAL FOR THE CICLESONIDE HFA METERED DOSE INHALER
16444 A III 2/3/2003 3M DRUG DELIVERY SYSTEMS CICLESONIDE HFA METERED DOSE INHALER ACTUATORS
16606 A II 5/21/2003 DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIK CICLESONIDE
19028 A II 12/13/2005 MICRONISIERUNGS KONTOR OBERROT GMBH CICLESONIDE, MICRONIZED (ITEM NO. 37)
22587 A II 2/27/2009 STERLING SPA CICLESONIDE
23650 A II 3/23/2010 AARTI INDUSTRIES LTD CICLESONIDE
24255 I II 9/10/2010 ALP PHARM BEIJING CO LTD CICLESONIDE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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