Application Sponsors
ANDA 211077 | PERRIGO PHARMA INTL | |
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2019-03-15 | STANDARD |
Submissions Property Types
CDER Filings
PERRIGO PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 211077
[companyName] => PERRIGO PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"AZELAIC ACID","activeIngredients":"AZELAIC ACID","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/15\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-03-15
)
)