Drug Master Files for: rosuvastatin calcium
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rosuvastatin calcium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20592 | A | II | 6/12/2007 | GLENMARK PHARMACEUTICALS LTD | ROSUVASTATIN CALCIUM |
| 20629 | A | II | 6/22/2007 | AUROBINDO PHARMA LTD | ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) |
| 20671 | A | II | 7/12/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ROSUVASTATIN CALCIUM (BULK) |
| 20677 | A | II | 7/2/2007 | ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD | ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3) |
| 20705 | A | II | 7/18/2007 | CHANGZHOU PHARMACEUTICAL FACTORY | ROSUVASTATIN CALCIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
