Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | FOSAMAX | ALENDRONATE SODIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-04-27 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2004-02-20 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2004-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2005-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2005-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2010-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2008-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2010-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2012-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2010-03-01 | STANDARD |
| REMS; REMS | SUPPL | 20 | AP | 2011-01-25 | N/A |
| REMS; REMS | SUPPL | 21 | AP | 2011-07-01 | N/A |
| LABELING; Labeling | SUPPL | 22 | AP | 2013-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2013-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2015-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2015-11-30 | STANDARD |
Submissions Property Types
| SUPPL | 12 | Null | 7 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
CDER Filings
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