Drug Master Files for: lactulose
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lactulose Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10145 | A | II | 3/19/1993 | CANLAC GROUP ABBOTT LABORATORIES LTD | LACTULOSE CONCENTRATE USP |
11262 | I | II | 12/25/1994 | INALCO SPA | LACTULOSE CRYSTALS |
11448 | I | II | 4/11/1995 | SOLVAY DUPHAR BV | LACTULOSE CONCENTRATE |
12699 | I | II | 10/14/1997 | SOLVAY DUPHAR BV | LACTULOSE CRYSTALLINE |
15253 | A | II | 2/16/2001 | FRESENIUS KABI AUSTRIA GMBH | LACTULOSE SOLUTION USP |
15254 | A | II | 2/16/2001 | FRESENIUS KABI AUSTRIA GMBH | LACTULOSE CRYSTALS |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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