Drug Master Files for: TAMOXIFEN CITRATE
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TAMOXIFEN CITRATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10681 | I | II | 12/15/1993 | CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD | TAMOXIFEN CITRATE |
| 15121 | I | II | 10/31/2000 | EGIS PHARMACEUTICALS PRIVATE LTD | TAMOXIFEN CITRATE BULK |
| 19284 | I | II | 3/8/2006 | YANGTZE RIVER PHARMACY GROUP JIANGSU HAI CI BIOLOGICAL PHARMACY CO LTD | TAMOXIFEN CITRATE USP |
| 21757 | I | II | 6/5/2008 | OLON SPA | TAMOXIFEN CITRATE |
| 27466 | A | II | 8/26/2013 | ASYMCHEM LABORATORIES TIANJIN CO LTD | TAMOXIFEN CITRATE |
| 4734 | I | II | 12/1/1982 | LEIRAS PHARMACEUTICALS | TAMOXIFEN CITRATE TABLETS |
| 4793 | I | II | 1/12/1983 | LEIRAS PHARMACEUTICALS | TAMOXIFEN CITRATE, BULK FORM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
