Application Sponsors
| ANDA 202640 | MYLAN PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 12.5MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 25MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 50MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-09-17 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-12-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202640
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-23
)
)