Application Sponsors
Marketing Status
Application Products
001 | TABLET, CHEWABLE;ORAL | 25MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-12-11 | |
LABELING; Labeling | SUPPL | 4 | AP | 1990-03-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-05-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-07-07 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 88733
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)