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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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