Application Sponsors
ANDA 203269 | ALKEM LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 5MG BASE | 0 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE |
002 | TABLET;ORAL | EQ 10MG BASE | 0 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-02-18 | |
LABELING; Labeling | SUPPL | 3 | AP | 2020-01-22 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2020-01-22 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 17 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ALKEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203269
[companyName] => ALKEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/22\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/22\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/19\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-22
)
)