Drug Master Files for: BECLOMETHASONE DIPROPIONATE MONOHYDRATE
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BECLOMETHASONE DIPROPIONATE MONOHYDRATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12813 | A | II | 1/5/1998 | FARMABIOS SPA | BECLOMETHASONE DIPROPIONATE |
| 13965 | I | II | 1/29/1999 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BECLOMETHASONE DIPROPIONATE MONOHYDRATE |
| 16934 | I | II | 10/20/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE |
| 18838 | A | III | 11/28/2005 | 3M DRUG DELIVERY SYSTEMS DIV | BECLOMETHASONE DIPROPIONATE HFA METERED DOSE INHALER VALVE |
| 19750 | A | II | 8/24/2006 | CIPLA LTD | BECLOMETHASONE DIPROPIONATE |
| 22648 | I | II | 12/9/2008 | MAHIMA LIFE SCIENCES PRIVATE LTD | BECLOMETHASONE DIPROPIONATE USP |
| 23030 | I | II | 7/31/2009 | ALP PHARM BEIJING CO LTD | BECLOMETHASONE DIPROPIONATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
