Drug Master Files for: CHOLIC ACID
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CHOLIC ACID Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11379 | A | II | 3/13/1995 | DIPHARMA FRANCIS SRL | URSODEOXYCHOLIC ACID |
| 12676 | I | II | 10/1/1997 | PRODOTTI CHIMICI DOTTORI RE | CHENODIOL, (CHENODEOXYCHOLIC ACID) |
| 2001 | I | II | 9/29/1972 | ROUSSEL CORP | CHENODEOXYCHOLIC ACID |
| 2107 | I | 5/21/1973 | ARMOUR PHARMACEUTICAL CO | TAUROCHOLIC ACID | |
| 21434 | I | II | 3/17/2008 | DAEWOONG BIO INC | URSODIOL USP (URSODEOXYCHOLIC ACID) |
| 2157 | I | II | 10/1/1973 | WEDDEL PHARMS LTD | CHENODEOXYCHOLIC ACID (CHENDOL) |
| 21692 | I | II | 6/7/2008 | ERREGIERRE SPA | CHENODEOXYCHOLIC ACID EP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
