Documents
Application Sponsors
NDA 020707 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SKELID | TILUDRONATE DISODIUM |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1997-03-07 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2003-08-21 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2006-11-17 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2010-03-19 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
Accessdata Error
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