Documents
Application Sponsors
ANDA 077498 | SUN PHARM INDS LTD | |
Marketing Status
Over-the-counter | 001 |
Over-the-counter | 002 |
Over-the-counter | 003 |
Over-the-counter | 004 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE |
002 | TABLET;ORAL | 10MG | 0 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE |
003 | TABLET;ORAL | 5MG | 0 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE |
004 | TABLET;ORAL | 10MG | 0 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2007-12-27 | |
LABELING; Labeling | SUPPL | 5 | AP | 2011-02-15 | |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 77498
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/27\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/077498lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CETIRIZINE HYDROCHLORIDE HIVES","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CETIRIZINE HYDROCHLORIDE HIVES","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2007-12-27
)
)