Application Sponsors
| ANDA 202890 | ZYDUS PHARMS USA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | 0 | ZOLMITRIPTAN | ZOLMITRIPTAN |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | 0 | ZOLMITRIPTAN | ZOLMITRIPTAN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-05-15 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-02-03 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-06-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202890
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/03\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-09
)
)