Drug Master Files for: RALOXIFENE HYDROCHLORIDE
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RALOXIFENE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15932 | A | II | 4/10/2002 | ERREGIERRE SPA | RALOXIFENE HYDROCHLORIDE |
| 16143 | A | II | 9/23/2002 | DR REDDYS LABORATORIES LTD | RALOXIFENE HYDROCHLORIDE USP |
| 17415 | I | II | 5/24/2004 | EXCELLA GMBH | RALOXIFENE HYDROCHLORIDE |
| 20163 | I | II | 1/17/2007 | CIPLA LTD | RALOXIFENE HYDROCHLORIDE |
| 21327 | I | II | 2/11/2008 | TEVA PHARMACEUTICALS INDUSTRIES LTD | RALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE |
| 21650 | A | II | 5/22/2008 | AARTI DRUGS LTD | RALOXIFENE HYDROCHLORIDE USP |
| 21682 | A | II | 6/5/2008 | TORRENT PHARMACEUTICALS LTD | RALOXIFENE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
