Application Sponsors
Marketing Status
Application Products
001 | SYRUP;ORAL | 10MG/5ML | 0 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-02-26 | STANDARD |
Submissions Property Types
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 210634
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-26
)
)