Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 60MG | 1 | EVISTA | RALOXIFENE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1997-12-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1998-11-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1999-09-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-05-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-06-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 2000-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2000-12-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2001-07-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-01-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2002-06-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-05-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-12-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 2007-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2007-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2016-01-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2016-01-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 2018-06-27 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 15 |
TE Codes
CDER Filings
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