Documents
Application Sponsors
ANDA 209107 | AUROBINDO PHARMA LTD | |
Marketing Status
Over-the-counter | 001 |
Over-the-counter | 002 |
Application Products
001 | CAPSULE;ORAL | 10MG | 0 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE |
002 | CAPSULE;ORAL | 10MG | 0 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-07-20 | STANDARD |
Submissions Property Types
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209107
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES RELIEF","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209107Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-07-20
)
)