Drug Master Files for: pitavastatin calcium
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pitavastatin calcium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14660 | A | II | 1/11/2000 | NISSAN CHEMICAL CORP | PITAVASTATIN CALCIUM |
| 23488 | A | II | 1/27/2010 | MSN LABORATORIES PRIVATE LTD | PITAVASTATIN CALCIUM [ROUTE CODE: PC] |
| 25956 | A | II | 4/11/2012 | SOLARA A PHARMA SCIENCES LTD | PITAVASTATIN CALCIUM |
| 26406 | I | II | 12/16/2012 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | PITAVASTATIN CALCIUM |
| 27106 | A | II | 5/7/2013 | AUROBINDO PHARMA LTD | PITAVASTATIN CALCIUM (NON-STERILE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
