Drug Master Files for: Daiichi Sankyo
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Daiichi Sankyo Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10102 | A | II | 2/26/1993 | DAIICHI SANKYO CO LTD | LEVOFLOXACIN DRUG SUBSTANCE |
| 14321 | I | II | 7/29/1999 | DAIICHI SANKYO CO LTD | CS-011 DRUG PRODUCT |
| 14884 | A | II | 5/15/2000 | DAIICHI SANKYO EUROPE GMBH | CS-866(5 10 20 & 40MG) TABLETS |
| 14953 | A | II | 7/14/2000 | DAIICHI SANKYO CO LTD | OLMESARTAN MEDOXOMIL DRUG SUBSTANCE |
| 15780 | I | II | 12/20/2001 | DAIICHI SANKYO CO LTD | DATICHI PHARMACEUTICAL CO LTD DU-6859A |
| 15906 | I | II | 3/19/2002 | DAIICHI SANKYO CO LTD | CS-758 DRUG PRODUCT |
| 15908 | I | II | 3/20/2002 | DAIICHI SANKYO CO LTD | CS-758 DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
