Drug Master Files for: SUCRALFATE
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SUCRALFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11876 | I | II | 2/28/1996 | BK GIULINI GMBH | SUCRALFATE POWDER |
| 16589 | A | II | 5/13/2003 | EUTICALS SPA | SUCRALFATE |
| 30056 | A | II | 2/3/2016 | ZHEJIANG HAISEN PHARMACEUTICAL CO LTD | SUCRALFATE NON STERILE BULK DRUG SUBSTANCE |
| 3542 | A | II | 6/12/1979 | CHUGAI PHARMACEUTICAL CO LTD | SUCRALFATE |
| 5454 | I | II | 6/25/1984 | ORION CORP LTD | SUCRALFATE |
| 5825 | I | II | 5/14/1985 | ORGAMOL SA | SUCRALFATE |
| 6048 | I | II | 9/27/1985 | NIPPON KAYAKU CO LTD | SUCRALFATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
