Drug Master Files for: amifostine
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amifostine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17186 | A | II | 2/26/2004 | SUN PHARMACEUTICAL INDUSTRIES LTD | AMIFOSTINE USP |
18898 | I | II | 10/8/2005 | AXITEC CO LTD | AMIFOSTINE USP (NON-STERILE BULK DRUG) |
21765 | A | II | 6/26/2008 | LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD | AMIFOSTINE |
22873 | I | II | 5/26/2009 | CHANGZHOU AHK TECH INC | AMIFOSTINE |
22909 | A | II | 6/26/2009 | ALBEMARLE CORP | AMIFOSTINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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