Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 70MG BASE;2,800 IU | 1 | FOSAMAX PLUS D | ALENDRONATE SODIUM; CHOLECALCIFEROL |
| 002 | TABLET;ORAL | EQ 70MG BASE;5,600 IU | 1 | FOSAMAX PLUS D | ALENDRONATE SODIUM; CHOLECALCIFEROL |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2005-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2006-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-12-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2007-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2008-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2010-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2010-03-01 | STANDARD |
| REMS; REMS | SUPPL | 13 | AP | 2011-01-25 | N/A |
| REMS; REMS | SUPPL | 15 | AP | 2011-07-01 | N/A |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-11-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2015-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2015-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-08-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
CDER Filings
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(
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[labels] =>
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