Documents
Application Sponsors
ANDA 090372 | DR REDDYS LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | ZAFIRLUKAST | ZAFIRLUKAST |
002 | TABLET;ORAL | 20MG | 0 | ZAFIRLUKAST | ZAFIRLUKAST |
FDA Submissions
| ORIG | 1 | AP | 2010-11-18 | |
LABELING; Labeling | SUPPL | 2 | AP | 2014-03-07 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90372
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ZAFIRLUKAST","activeIngredients":"ZAFIRLUKAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZAFIRLUKAST","activeIngredients":"ZAFIRLUKAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ZAFIRLUKAST","submission":"ZAFIRLUKAST","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZAFIRLUKAST","submission":"ZAFIRLUKAST","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)