Drug Master Files for: SUCRALFATE
✉ Email this page to a colleague
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 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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