Drug Master Files for: ORLISTAT
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ORLISTAT Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18315 | A | III | 4/28/2005 | NYPRO INC | ORLISTAT 60 MG PORTABLE PACKAGE (R) |
| 22110 | I | II | 10/24/2008 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | ORLISTAT |
| 22357 | I | II | 12/30/2008 | SUN PHARMACEUTICAL INDUSTRIES LTD | ORLISTAT (NON-STERILE BULK) |
| 23978 | A | II | 7/19/2010 | FORMOSA LABORATORIES INC | ORLISTAT USP |
| 24885 | A | II | 4/12/2011 | CHONGQING ZEIN PHARMACEUTICAL CO LTD | ORLISTAT |
| 26101 | A | II | 5/18/2012 | BIOCON LTD | ORLISTAT |
| 26455 | A | II | 9/21/2012 | ARGUS PHARMACEUTICALS LTD | ORLISTAT |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
