Drug Master Files for: dexrazoxane
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dexrazoxane Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15184 | I | II | 12/7/2000 | BOEHRINGER INGELHEIM CHEMICALS INC | DEXRAZOXANE |
18336 | A | II | 5/9/2005 | ALCAMI WISCONSIN CORP | DEXRAZOXANE |
19002 | A | II | 12/5/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DEXRAZOXANE (ICRF-187) |
21542 | A | II | 4/17/2008 | BIOCARE PHARMACEUTICAL LTD | DEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCE |
23172 | A | II | 9/22/2009 | GLAND PHARMA LTD | DEXRAZOXANE |
27826 | A | II | 2/4/2014 | GLAND PHARMA LTD | DEXRAZOXANE (PROCESS-II) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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