Drug Master Files for: valsartan
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valsartan Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17897 | I | II | 12/15/2004 | SUN PHARMACEUTICAL INDUSTRIES LTD | VALSARTAN USP |
| 17909 | A | II | 12/16/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | VALSARTAN |
| 18253 | A | II | 4/7/2005 | MYLAN LABORATORIES LTD | VALSARTAN USP |
| 18967 | A | II | 11/22/2005 | JUBILANT GENERICS LTD | VALSARTAN USP |
| 19301 | A | II | 3/27/2006 | LUPIN LTD | VALSARTAN USP |
| 20319 | A | II | 3/2/2007 | DR REDDYS LABORATORIES LTD | VALSARTAN |
| 20939 | I | II | 9/24/2007 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | VALSARTAN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
