Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | SUSPENSION;ORAL | 12.5MG/5ML | 0 | VIOXX | ROFECOXIB |
| 002 | SUSPENSION;ORAL | 25MG/5ML | 0 | VIOXX | ROFECOXIB |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1999-05-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-03-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2000-03-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2002-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2002-04-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2002-04-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2002-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2002-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-06-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2003-05-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2003-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2003-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2003-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2003-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2003-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2004-08-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 21 | AP | 2004-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2016-05-09 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 19 | Null | 26 |
| SUPPL | 24 | Null | 6 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21052
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)