Application Sponsors
| ANDA 201993 | MYLAN PHARMS INC | |
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 | 2012-12-31 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-09-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-09-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201993
[companyName] => MYLAN PHARMS INC
[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":"12\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/21\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-21
)
)