Drug Master Files for: loteprednol etabonate
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loteprednol etabonate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11105 | A | II | 9/26/1994 | ZACH SYSTEM SA | LOTEPREDNOL ETABONATE |
| 11264 | I | II | 12/16/1994 | FINE ORGANICS LTD | LO287 (CRUDE LOTEPREDNOL ETABONATE) |
| 22278 | I | II | 12/2/2008 | ALP PHARM BEIJING CO LTD | LOTEPREDNOL ETABONATE |
| 23672 | A | II | 4/1/2010 | INDUSTRIALE CHIMICA SRL | LOTEPREDNOL ETABONATE |
| 25435 | I | II | 12/6/2011 | RELIANCE LIFE SCIENCES PVT LTD | LOTEPREDNOL ETABONATE |
| 26249 | A | II | 7/26/2012 | AARTI INDUSTRIES LTD | LOTEPREDNOL ETABONATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
