Drug Master Files for: lubiprostone
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lubiprostone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18076 | A | II | 2/11/2005 | CATALENT PHARMA SOLUTIONS LLC | LUBIPROSTONE, 24 MCG CAPSULES |
| 18091 | A | II | 2/18/2005 | SUCAMPO PHARMA AMERICAS LLC | LUBIPROSTONE (RU-0211) |
| 23383 | A | II | 12/17/2009 | EVERLIGHT CHEMICAL INDUSTRIAL CORP | LUBIPROSTONE |
| 23402 | I | II | 12/23/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LUBIPROSTONE |
| 23490 | I | II | 1/28/2010 | APOTEX PHARMACHEM INC | LUBIPROSTONE |
| 24286 | I | II | 11/8/2010 | FIS FABBRICA ITALIANA SINTETICI SPA | LUBIPROSTONE |
| 24705 | A | II | 3/29/2011 | DR REDDYS LABORATORIES EU LTD | LUBIPROSTONE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
