Drug Master Files for: LOVASTATIN
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LOVASTATIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11336 | I | II | 12/2/1996 | ANTIBIOTIC CO | LOVASTATIN |
| 11502 | A | II | 5/12/1995 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LOVASTATIN USP |
| 12133 | A | II | 9/17/1996 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | LOVASTATIN USP |
| 12400 | I | II | 3/2/1997 | ZHEJIANG RUIBANG LABORATORIES INC | LOVASTATIN |
| 12481 | I | II | 4/25/1997 | SYNGEN BIOTECH CO LTD | LOVASTATIN |
| 12496 | I | II | 5/8/1997 | CHONGQING DAXIN PHARMACEUTICAL CO LTD | LOVASTATIN, USP |
| 13248 | I | II | 9/30/1998 | ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV | LOVASTATIN, USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
