Documents
Application Sponsors
ANDA 079043 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
002 | TABLET, EXTENDED RELEASE;ORAL | 180MG;240MG | 0 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-03-17 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-06-22 | |
LABELING; Labeling | SUPPL | 5 | AP | 2016-01-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2022-05-17 | UNKNOWN |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 7 |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 79043
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"180MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"180MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)