Drug Master Files for: ATORVASTATIN CALCIUM
✉ Email this page to a colleague
ATORVASTATIN CALCIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16098 | I | II | 8/19/2002 | RANBAXY LABORATORIES LTD | ATORVASTATIN CALCIUM(AMORPHOUS) |
| 17484 | I | II | 6/21/2004 | RANBAXY LABORATORIES LTD | ATORVASTATIN MAGNESIUM |
| 18082 | A | II | 2/1/2005 | LEK PHARMACEUTICALS DD | ATORVASTATIN CALCIUM |
| 18122 | I | II | 2/23/2005 | MOREPEN LABORATORIES LTD | ATORVASTATIN CALCIUM |
| 18402 | I | II | 6/6/2005 | MOREPEN LABORATORIES LTD | ATORVASTATIN CALCIUM AMORPHOUS, BULK 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
