Application Sponsors
| ANDA 091567 | SUN PHARM INDS | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
| Over-the-counter | 003 |
| Over-the-counter | 004 |
| Over-the-counter | 005 |
| Over-the-counter | 006 |
Application Products
| 001 | TABLET;ORAL | 30MG | 0 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 30MG | 0 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 60MG | 0 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 60MG | 0 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE |
| 005 | TABLET;ORAL | 180MG | 0 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE |
| 006 | TABLET;ORAL | 180MG | 0 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE |
FDA Submissions
Submissions Property Types
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 91567
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)