Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MAXALT | RIZATRIPTAN BENZOATE |
| 002 | TABLET;ORAL | EQ 10MG BASE | 1 | MAXALT | RIZATRIPTAN BENZOATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1998-06-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2000-06-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1999-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-12-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2000-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2001-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2000-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2002-04-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2011-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2010-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2011-12-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 2011-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2014-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2015-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-10-01 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 8 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 7 |
TE Codes
CDER Filings
MERCK
cder:Array
(
[0] => Array
(
[ApplNo] => 20864
[companyName] => MERCK
[docInserts] => ["",""]
[products] => [{"drugName":"MAXALT","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MAXALT","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020864s023,020865s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020864s023,020865s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-18","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2010","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020864s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20864lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MAXALT","submission":"RIZATRIPTAN BENZOATE","actionType":"EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MAXALT","submission":"RIZATRIPTAN BENZOATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-01
)
)