Application Sponsors
| ANDA 200161 | NATCO PHARMA LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 2.5MG | 0 | LETROZOLE | LETROZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2011-06-03 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
CDER Filings
NATCO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 200161
[companyName] => NATCO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/03\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/07\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/07\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-20
)
)