Application Sponsors
ANDA 076011 | PERRIGO PHARMA INTL | |
Marketing Status
Application Products
001 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 0 | LORATADINE | LORATADINE |
FDA Submissions
CDER Filings
PERRIGO PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 76011
[companyName] => PERRIGO PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LORATADINE","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)