Application Sponsors
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | TABLET;ORAL | 60MG | 0 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 180MG | 0 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2020-02-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2022-07-08 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2022-11-04 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 14 | Null | 7 |
CDER Filings
L PERRIGO CO
cder:Array
(
[0] => Array
(
[ApplNo] => 212971
[companyName] => L PERRIGO CO
[docInserts] => ["",""]
[products] => [{"drugName":"FEXOFENADINE HYDROCHLORIDE","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-02-24
)
)