Drug Master Files for: olmesartan medoxomil
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olmesartan medoxomil Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14953 | A | II | 7/14/2000 | DAIICHI SANKYO CO LTD | OLMESARTAN MEDOXOMIL DRUG SUBSTANCE |
| 19141 | A | II | 1/31/2006 | GLENMARK PHARMACEUTICALS LTD | OLMESARTAN MEDOXOMIL, USP |
| 19384 | A | II | 4/20/2006 | DR REDDYS LABORATORIES LTD | OLMESARTAN MEDOXOMIL |
| 19629 | I | II | 7/25/2006 | DAIICHI SANKYO CO LTD | BENICAR HCTR (OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE) TABLETS |
| 20417 | A | II | 3/23/2007 | MYLAN LABORATORIES LTD | OLMESARTAN MEDOXOMIL USP |
| 21931 | A | II | 9/4/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | OLMESARTAN MEDOXOMIL |
| 22721 | I | II | 4/14/2009 | AMINO CHEMICALS LTD | OLMESARTAN MEDOXOMIL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
