Drug Master Files for: ATOVAQUONE
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ATOVAQUONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20672 | I | II | 7/6/2007 | USV LTD | ATOVAQUONE USP |
| 20908 | A | II | 10/3/2007 | CADILA HEALTHCARE LTD | ATOVAQUONE USP |
| 21001 | I | II | 10/1/2007 | ZHEJIANG HISOAR PHARMACEUTICAL CO LTD | Atovaquone |
| 21360 | A | II | 2/15/2008 | ROLABO OUTSOURCING SL | ATOVAQUONE USP |
| 21468 | I | II | 3/28/2008 | EXCELLA GMBH | ATOVAQUONE |
| 22057 | A | II | 10/1/2008 | ALCHYMARS ICM SM PRIVATE LTD | ATOVAQUONE USP |
| 22121 | A | II | 10/27/2008 | GLENMARK PHARMACEUTICALS LTD | ATOVAQUONE, 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
