Application Sponsors
| ANDA 203266 | CADILA PHARMS LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 600MG | 0 | GEMFIBROZIL | GEMFIBROZIL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-06-17 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-12-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 17 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
CDER Filings
CADILA PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203266
[companyName] => CADILA PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"GEMFIBROZIL","activeIngredients":"GEMFIBROZIL","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/13\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/11\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-12-13
)
)