Drug Master Files for: ifosfamide
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ifosfamide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11290 | A | II | 1/11/1995 | JIANGSU HENGRUI MEDICINE CO LTD | IFOSFAMIDE USP, NON-STERILE, BULK DRUG SUBSTANCE |
14796 | I | II | 3/28/2000 | DEGUSSA HULS AG | IFOSFAMIDE CRUDE |
15064 | A | II | 9/29/2000 | IFOTAM CO LTD | IFOSFAMIDE |
25081 | A | II | 7/20/2009 | AARTI INDUSTRIES LTD | IFOSFAMIDE |
3506 | A | II | 4/24/1979 | BAXTER HEALTHCARE CORP | IFOSFAMIDE USP/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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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