Application Sponsors
ANDA 210033 | PERRIGO PHARMA INTL | |
Marketing Status
Application Products
001 | TABLET, CHEWABLE;ORAL | 5MG | 0 | LORATADINE | LORATADINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-06-12 | STANDARD |
Submissions Property Types
CDER Filings
PERRIGO PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 210033
[companyName] => PERRIGO PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-06-12
)
)