Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MAXALT-MLT | RIZATRIPTAN BENZOATE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | 1 | MAXALT-MLT | RIZATRIPTAN BENZOATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-06-29 | STANDARD |
| S; Supplement | SUPPL | 2 | AP | 2000-06-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-03-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2000-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2000-12-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2000-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2000-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2001-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2002-04-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2010-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2011-12-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 21 | AP | 2011-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2014-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-10-01 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 15 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20865
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)