Drug Master Files for: PRAVASTATIN SODIUM
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PRAVASTATIN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14235 | A | II | 6/24/1999 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | PRAVASTATIN SODIUM USP |
| 14729 | A | II | 2/25/2000 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PRAVASTATIN SODIUM |
| 15922 | I | II | 4/3/2002 | LEK PHARMACEUTICALS DD | PRAVASTATIN SODIUM |
| 16031 | I | II | 6/26/2002 | RANBAXY LABORATORIES LTD | PRAVASTATIN SODIUM |
| 16048 | A | II | 7/12/2002 | BIOCON LTD | PRAVASTATIN SODIUM USP |
| 16204 | I | II | 10/22/2002 | LEK PHARMACEUTICALS DD | PRAVASTATIN SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
