Drug Master Files for: isoflurane
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isoflurane Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10363 | I | II | 7/19/1993 | GREAT LAKES CHEMICAL CORP | ISOFLURANE |
10364 | I | II | 7/19/1993 | GREAT LAKES CHEMICAL CORP | FACILITY FOR THE MANUFACTURE OF ISOFLURANE IN WEST LAFAYETTE, INDIANA. |
12045 | I | II | 7/15/1996 | GREAT LAKES CHEMICAL CORP | ISOFLURANE |
18995 | A | II | 11/28/2005 | SHANDONG NEW TIME PHARMACEUTICAL CO LTD | ISOFLURANE (NON-STERILE BULK) |
2325 | I | II | 9/10/1974 | OHIO MEDICAL PRODUCTS DIV AIRCO INC | ETHRANE (ENFLURANE) FORANE (ISOFLURANE) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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