Drug Master Files for: losartan potassium
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losartan potassium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16311 | I | II | 12/16/2002 | MAPRIMED SA | LOSARTAN POTASSIUM |
| 16526 | I | II | 4/5/2003 | IPCA LABORATORIES LTD | LOSARTAN POTASSIUM |
| 16996 | A | II | 12/3/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LOSARTAN POTASSIUM |
| 17460 | A | II | 6/10/2004 | IPCA LABORATORIES LTD | LOSARTAN POTASSIUM USP (PROCESS II) |
| 17833 | I | II | 11/8/2004 | MEDICHEM SA | LOSARTAN POTASSIUM |
| 17867 | I | II | 12/1/2004 | LEK PHARMACEUTICALS DD | LOSARTAN POTASSIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
