Drug Master Files for: cyclophosphamide
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cyclophosphamide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13050 | I | II | 7/2/1998 | LIANYUNGANG PHARMACEUTICAL FACTORY | CYCLOPHOSPHAMIDE USP,NON-STERILE BULK DRUG |
14830 | I | II | 4/14/2000 | DEGUSSA HULS AG | CYCLOPHOSPHAMIDE |
15178 | A | II | 12/1/2000 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | CYCLOPHOSPHAMIDE USP |
17065 | I | II | 12/23/2003 | OLAINFARM JOINT STOCK CO | CYCLOPHOSPHAMIDE |
22794 | I | II | 5/21/2009 | EMCURE PHARMACEUTICALS LTD | CYCLOPHOSPHAMIDE USP |
26041 | A | II | 5/11/2012 | JIANGSU HENGRUI MEDICINE CO LTD | CYCLOPHOSPHAMIDE, USP, STERILE, BULK DRUG SUBSTANCE |
26137 | A | II | 6/8/2012 | SUNNY PHARMTECH INC | CYCLOPHOSPHAMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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