Drug Master Files for: ursodiol
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ursodiol Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16803 | A | II | 9/3/2003 | PRODOTTI CHIMICI E ALIMENTARI SPA | URSODIOL |
| 17717 | I | II | 10/19/2004 | AXCAN PHARMA INC | URSODIOL SUSPENSION, 250 MG/ML |
| 21434 | I | II | 3/17/2008 | DAEWOONG BIO INC | URSODIOL USP (URSODEOXYCHOLIC ACID) |
| 25536 | A | II | 11/16/2011 | DAEWOONG BIO INC | URSODIOL USP (PROCESS I) |
| 28994 | A | II | 2/10/2015 | DAEWOONG BIO INC | URSODIOL USP (PROCESS II) |
| 31403 | A | II | 6/23/2017 | SOLARA A PHARMA SCIENCES LTD | URSODEOXYCHOLIC ACID (URSODIOL) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
